Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug

ID: NCT03235726
Status: Recruiting
Phase: Phase 1
Start Date: July 13, 2017
First Submitted: July 11, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: GlaxoSmithKline
Sponsors & Collaborators: GlaxoSmithKline
Location: United Kingdom
Conditions: Pulmonary Disease, Chronic Obstructive
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Study Description

Brief Summary

This single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of the CCI15106 inhalation powder. The study will also look at the level of CCI15106 that will be released into the air and may be found in the blood of the people standing around the person inhaling it (bystanders). This is a two-part study in which Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part 2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and approximately 22 subjects with COPD will be randomized in this study for dosing. The total study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.

Detailed Description

Condition or disease Intervention/treatment Phase

Pulmonary Disease, Chronic Obstructive

Drug: CCI15106
Other Names
Drug: Placebo
Other Names
Phase 1

Tracking Information

First Submitted DateJuly 11, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateJuly 13, 2017
Anticipated Completion DateMay 15, 2018
Actual Primary Completion DateMarch 22, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Number of subjects with adverse events (AEs) and serious AEs (SAEs): Cohort A Part 1 [Time Frame: Up to Day 52]

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.

  • Number of subjects with AEs, SAEs: Cohort B-C Part 1 [Time Frame: Up to Day 45]

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.

  • Number of subjects with AEs, SAEs: Cohort A Part 2 [Time Frame: Up to Day 32]

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.

  • Number of subjects with AEs, SAEs: Cohort B Part 2 [Time Frame: Up to Day 45]

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.

  • Number of subjects with abnormal clinical chemistry findings: Cohort A Part 1 [Time Frame: Up to Day 52]

    Clinical chemistry parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal clinical chemistry findings: Cohort B-C Part 1 [Time Frame: Up to Day 45]

    Clinical chemistry parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal clinical chemistry findings: Cohort A Part 2 [Time Frame: Up to day 32]

    Clinical chemistry parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal clinical chemistry findings: Cohort B Part 2 [Time Frame: Up to Day 45]

    Clinical chemistry parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal hematology findings: Cohort A Part 1 [Time Frame: Up to Day 52]

    Clinical hematology parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal clinical hematology findings: Cohort B-C Part 1 [Time Frame: Up to Day 45]

    Clinical hematology parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal clinical hematology findings: Cohort A Part 2 [Time Frame: Up to Day 32]

    Clinical hematology parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal clinical hematology findings: Cohort B Part 2 [Time Frame: Up to Day 45]

    Clinical hematology parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal urinalysis findings: Cohort A Part 1 [Time Frame: Up to Day 52]

    Urine analysis parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal urinalysis findings: Cohort B-C Part 1 [Time Frame: Up to Day 45]

    Urine analysis parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal urinalysis findings: Cohort A Part 2 [Time Frame: Up to Day 32]

    Urine analysis parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal urinalysis findings: Cohort B Part 2 [Time Frame: Up to Day 45]

    Urine analysis parameters will be analyzed as a measure of safety.

  • Number of subjects with abnormal electrocardiogram (ECG) findings: Cohort A Part 1 [Time Frame: Up to day 52]

    Triplicate or single 12-lead ECG will be obtained in semi-supine position after 5 minutes using an ECG machine.

  • Number of subjects with abnormal ECG findings: Cohort B-C Part 1 [Time Frame: Up to Day 45]

    Triplicate or single 12-lead ECG will be obtained in semi-supine position after 5 minutes using an ECG machine.

  • Number of subjects with abnormal ECG findings: Cohort A Part 2 [Time Frame: Up to Day 32]

    Triplicate or single 12-lead ECG will be obtained in semi-supine position after 5 minutes using an ECG machine.

  • Number of subjects with abnormal ECG findings: Cohort B Part 2 [Time Frame: Up to Day 45]

    Triplicate or single 12-lead ECG will be obtained in semi-supine position after 5 minutes using an ECG machine.

  • Number of subjects with abnormal telemetry findings: Cohort A Part 1 [Time Frame: Up to Day 18]

    Continuous cardiac telemetry will be performed at given time points.

  • Number of subjects with abnormal telemetry findings: Cohort B part 1 [Time Frame: Up to Day 13]

    Continuous cardiac telemetry will be performed at given time points.

  • Number of subjects with abnormal telemetry findings: Cohort A Part 2 [Time Frame: Day 1]

    Continuous cardiac telemetry will be performed at given time points.

  • Number of subjects with abnormal telemetry findings: Cohort B Part 2 [Time Frame: Up to Day 13]

    Continuous cardiac telemetry will be performed at given time points.

  • Number of subjects with abnormal spirometry findings: Cohort A Part 1 [Time Frame: Up to Day 19]

    Spirometry measurements will be performed at specific time points using a spirometer.

  • Number of subjects with abnormal spirometry findings: Cohort B Part 1 [Time Frame: Up to Day 14]

    Spirometry measurements will be performed at specific time points using a spirometer.

  • Number of subjects with abnormal spirometry findings: Cohort A Part 2 [Time Frame: Day 1]

    Spirometry measurements will be performed at specific time points using a spirometer.

  • Number of subjects with abnormal spirometry findings: Cohort B Part 2 [Time Frame: Up to Day 14]

    Spirometry measurements will be performed at specific time points using a spirometer.

  • Number of subjects with abnormal body temperature findings: Cohort A Part 1 [Time Frame: Up to Day 52]

    Oral or tympanic temperature will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal body temperature findings: Cohort B-C Part 1 [Time Frame: Up to Day 45]

    Oral or tympanic temperature will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal body temperature findings: Cohort A Part 2 [Time Frame: Up to Day 32]

    Oral or tympanic temperature will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal body temperature findings: Cohort B Part 2 [Time Frame: Up to Day 45]

    Oral or tympanic temperature will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal pulse rate findings: Cohort A Part 1 [Time Frame: Up to Day 52]

    Pulse rate will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal pulse rate findings: Cohort B-C Part 1 [Time Frame: Up to Day 45]

    Pulse rate will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal pulse rate findings: Cohort A Part 2 [Time Frame: Up to Day 32]

    Pulse rate will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal pulse rate findings: Cohort B Part 2 [Time Frame: Up to Day 45]

    Pulse rate will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal respiratory rate findings: Cohort A Part 1 [Time Frame: Up to Day 52]

    Respiratory rate will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal respiratory rate findings: Cohort B-C Part 1 [Time Frame: Up to Day 45]

    Respiratory rate will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal respiratory rate findings: Cohort A Part 2 [Time Frame: Up to Day 32]

    Respiratory rate will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal respiratory rate findings: Cohort B Part 2 [Time Frame: Up to Day 45]

    Respiratory rate will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal blood pressure findings: Cohort A Part 1 [Time Frame: Up to Day 52]

    Systolic and diastolic blood pressure will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal blood pressure findings: Cohort B-C Part 1 [Time Frame: Up to Day 45]

    Systolic and diastolic blood pressure will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal blood pressure findings: Cohort A Part 2 [Time Frame: Up to Day 32]

    Systolic and diastolic blood pressure will be assessed in a semi-supine position at specified time points.

  • Number of subjects with abnormal blood pressure findings: Cohort B Part 2 [Time Frame: Up to Day 45]

    Systolic and diastolic blood pressure will be assessed in a semi-supine position at specified time points.

  • Area under the curve (AUC) from time zero to the time of last quantifiable concentration (AUC[o-last]) of CCI15106: single dose in Part 1 and 2 [Time Frame: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)]

    Blood sample will be collected at given time points to study the Pharmacokinetics (PK) profile of CCI15106 given in single dose.

  • Maximum observed concentration (Cmax) of CCI15106: single dose in Part 1 and 2 [Time Frame: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)]

    Blood sample will be collected at given time points to study the PK profile of CCI15106 given in single dose.

  • Time required to reach Cmax (Tmax) of CCI15106: single dose in Part 1 and 2 [Time Frame: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)]

    Blood sample will be collected at given time points to study the PK profile of CCI15106 given in single dose.

  • AUC from time zero to infinity (AUC[o-inf]) of CCI15106: single dose Part 1 and 2 [Time Frame: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)]

    Blood sample will be collected at given time points to study the PK profile of CCI15106 given in single dose.

  • Elimination half-life (t1/2) of CCI15106: single dose Part 1 and 2 [Time Frame: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)]

    Blood sample will be collected at given time points to study the PK profile of CCI15106 given in single dose.

  • Clearance (CL/F) of CCI15106: single dose Part 1 and 2 [Time Frame: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)]

    Blood sample will be collected at given time points to study the PK profile of CCI15106 given in single dose.

  • AUC from time zero to end of dosing interval (AUC[o-tau]) of CCI15106: repeat dose Part 1 and 2 [Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1,2,4,6,8,10 and 12 hours on Days 6,19 (Cohort A Part 1) and on Days 1,14 (Cohort B Part 1,2); Pre-dose on Days 7, 9, 11, 13, 15, 17, 20, 21, 22 (Cohort A Part 1); Pre-dose on Days 2, 4, 6, 8, 10, 12, 15 (Cohort B Part 1,2)]

    Blood sample will be collected at given time points to study the PK profile of CCI15106 given in repeat dose.

  • Cmax of CCI15106: repeat dose Part 1 and 2 [Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1,2,4,6,8,10 and 12 hours on Days 6,19 (Cohort A Part 1) and on Days 1,14 (Cohort B Part 1,2); Pre-dose on Days 7, 9, 11, 13, 15, 17, 20, 21, 22 (Cohort A Part 1); Pre-dose on Days 2, 4, 6, 8, 10, 12, 15 (Cohort B Part 1,2)]

    Blood sample will be collected at given time points to study the PK profile of CCI15106 given in repeat dose.

  • Tmax of CCI15106: repeat dose Part 1 and 2 [Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1,2,4,6,8,10 and 12 hours on Days 6,19 (Cohort A Part 1) and on Days 1,14 (Cohort B Part 1,2); Pre-dose on Days 7, 9, 11, 13, 15, 17, 20, 21, 22 (Cohort A Part 1); Pre-dose on Days 2, 4, 6, 8, 10, 12, 15 (Cohort B Part 1,2)]

    Blood sample will be collected at given time points to study the PK profile of CCI15106 given in repeat dose.

  • T1/2 of CCI15106: repeat dose Part 1 and 2 [Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1,2,4,6,8,10 and 12 hours on Days 6,19 (Cohort A Part 1) and on Days 1,14 (Cohort B Part 1,2); Pre-dose on Days 7, 9, 11, 13, 15, 17, 20, 21, 22 (Cohort A Part 1); Pre-dose on Days 2, 4, 6, 8, 10, 12, 15 (Cohort B Part 1,2)]

    Blood sample will be collected at given time points to study the PK profile of CCI15106 given in repeat dose.

  • Concentration of CCI15106 in plasma of bystanders: Cohort C Part 1 [Time Frame: Pre-dose, 15 minutes post-dose on Days 1, 7, 14 and anytime on Day 15]

    Blood samples will be collected from bystanders 15 minutes after dosing at given time points to study the concentration of CCI15106 in plasma of bystanders.

  • Amount of CCI15106 accumulated on filters fitted on stationary pumps: Part 1 [Time Frame: Up to Day 14]

    Static air samples will be collected on filters within air pumps during and after the first daily dose at given time points. Sampling devices attached to sampling pumps will be used to measure CCI15106 concentration.

  • Amount of CCI15106 accumulated on filters fitted on bystanders: Part 1 [Time Frame: Up to Day 14]

    Personal exposure air samples will be collected on filters placed on each bystander after the first daily dose at given time points. The filters will be used to measure CCI15106 concentration in the person's breathing zone.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Concentration of CCI15106 in lung epithelial lining fluid (ELF): Cohort B Part 1 [Time Frame: On Day 10,11,12,or 13]

    Bronchoalveolar lavage (BAL) samples for ELF concentration analysis of CCI15106 at given time points.

  • Concentration of CCI15106 in lung epithelial lining fluid (ELF): Cohort B Part 2 [Time Frame: On Day 10,11,12,or 13]

    Bronchoalveolar lavage (BAL) samples for ELF concentration analysis of CCI15106 at given time points.

  • Number of medical device incidents: Cohort A Part 1 [Time Frame: Up to Day 19]

    A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a subject/user/other person or to a serious deterioration in his/her state of health.

  • Number of medical device incidents: Cohort B Part 1 [Time Frame: Up to Day 14]

    A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a subject/user/other person or to a serious deterioration in his/her state of health.

  • Number of medical device incidents: Cohort A Part 2 [Time Frame: Day 1]

    A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a subject/user/other person or to a serious deterioration in his/her state of health.

  • Number of medical device incidents: Cohort B Part 2 [Time Frame: Up to Day 14]

    A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a subject/user/other person or to a serious deterioration in his/her state of health.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleStudy of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug
Official TitleA Double-blind (Sponsor Unblind), Randomized, Placebo-controlled, Single and Repeat Escalating Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of CCI15106 Inhalation Powder in Healthy Participants and Participants With Moderate Chronic Obstructive Pulmonary Disease (COPD) Including Evaluation of Environmental and Healthy By-stander Exposure Levels During Dosing
Brief Summary

This single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of the CCI15106 inhalation powder. The study will also look at the level of CCI15106 that will be released into the air and may be found in the blood of the people standing around the person inhaling it (bystanders). This is a two-part study in which Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part 2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and approximately 22 subjects with COPD will be randomized in this study for dosing. The total study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.

Detailed Description

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
58
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Pulmonary Disease, Chronic Obstructive
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: CCI15106

One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Other Names
Drug: Placebo

One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Other Names
Study Groups/Cohorts
Cohort A, Part 1: Active
60 milligrams (mg) single dose of CCI15106 will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered twice daily (BID) on Days 6-19 to healthy subjects.

Cohort A, Part 1: Placebo
60 mg single dose of placebo will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered BID on Days 6-19 to healthy subjects.

Cohort B, Part 1: Active
60 mg of CCI15106 BID will be administered by inhalation route for 14 days to healthy subjects.

Cohort B, Part 1: Placebo
60 mg of placebo BID will be administered by inhalation route for 14 days to healthy subjects.

Cohort C, Part 1: bystanders
Healthy subjects will be enrolled to follow bystander exposure and will be studied concomitantly with Cohort B.

Cohort A, Part 2: Active
60 mg single dose of CCI15106 will be administered by inhalation route to subjects with COPD.

Cohort A, Part 2: Placebo
60 mg single dose of placebo will be administered by inhalation route to subjects with COPD.

Cohort B, Part 2: Active
60 mg BID dose of CCI15106 will be administered by inhalation route for 14 days to subjects with COPD.

Cohort B, Part 2: Placebo
60 mg BID dose of placebo will be administered by inhalation route for 14 days to subjects with COPD.

Study Arms
Experimental Cohort A, Part 1: Active
60 milligrams (mg) single dose of CCI15106 will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered twice daily (BID) on Days 6-19 to healthy subjects.
Drug : CCI15106
One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Placebo Comparator Cohort A, Part 1: Placebo
60 mg single dose of placebo will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered BID on Days 6-19 to healthy subjects.
Drug : Placebo
One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Experimental Cohort A, Part 2: Active
60 mg single dose of CCI15106 will be administered by inhalation route to subjects with COPD.
Drug : CCI15106
One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Placebo Comparator Cohort A, Part 2: Placebo
60 mg single dose of placebo will be administered by inhalation route to subjects with COPD.
Drug : Placebo
One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Experimental Cohort B, Part 1: Active
60 mg of CCI15106 BID will be administered by inhalation route for 14 days to healthy subjects.
Drug : CCI15106
One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Placebo Comparator Cohort B, Part 1: Placebo
60 mg of placebo BID will be administered by inhalation route for 14 days to healthy subjects.
Drug : Placebo
One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Experimental Cohort B, Part 2: Active
60 mg BID dose of CCI15106 will be administered by inhalation route for 14 days to subjects with COPD.
Drug : CCI15106
One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Placebo Comparator Cohort B, Part 2: Placebo
60 mg BID dose of placebo will be administered by inhalation route for 14 days to subjects with COPD.
Drug : Placebo
One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Arm Intervention/Treatment
Experimental Cohort A, Part 1: Active
60 milligrams (mg) single dose of CCI15106 will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered twice daily (BID) on Days 6-19 to healthy subjects.
Drug : CCI15106
Placebo Comparator Cohort A, Part 1: Placebo
60 mg single dose of placebo will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered BID on Days 6-19 to healthy subjects.
Drug : Placebo
Experimental Cohort A, Part 2: Active
60 mg single dose of CCI15106 will be administered by inhalation route to subjects with COPD.
Drug : CCI15106
Placebo Comparator Cohort A, Part 2: Placebo
60 mg single dose of placebo will be administered by inhalation route to subjects with COPD.
Drug : Placebo
Experimental Cohort B, Part 1: Active
60 mg of CCI15106 BID will be administered by inhalation route for 14 days to healthy subjects.
Drug : CCI15106
Placebo Comparator Cohort B, Part 1: Placebo
60 mg of placebo BID will be administered by inhalation route for 14 days to healthy subjects.
Drug : Placebo
Experimental Cohort B, Part 2: Active
60 mg BID dose of CCI15106 will be administered by inhalation route for 14 days to subjects with COPD.
Drug : CCI15106
Placebo Comparator Cohort B, Part 2: Placebo
60 mg BID dose of placebo will be administered by inhalation route for 14 days to subjects with COPD.
Drug : Placebo

Recruitment Information

Recruitment Status:Recruiting
Enrollment58
Completion DateMay 15, 2018
Eligibility Criteria: Some important Inclusion Criteria:
For healthy subjects and bystanders:
- 18 to 65 years of age.
- Healthy as determined by a doctor.
- Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm during this period.
- Women who are not pregnant or breastfeeding, and not of childbearing potential.
For subjects with COPD:
- 40 to 75 years of age.
- Diagnosed with moderate COPD by a doctor.
- Have breathing test results that are consistent with moderate COPD as defined in the study protocol.
- A smoker or an ex-smoker.
- Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm during this period.
- Women who are not pregnant or breastfeeding, and not of childbearing potential.
Some Important
Exclusion Criteria:
For healthy subjects and bystanders:
- History of liver disease.
- Use of over-the-counter or prescription drugs (including vitamins) 7 days before the study until completion of the follow-up visit.
- Participation in the study would result in loss of more than 500 milliliter (mL) of blood within 3 months.
- Participation in another clinical trial with an investigational product within about 3 months before this study.
- Positive drug/alcohol screen.
- Regular use of known drugs of abuse.
- Regular alcohol consumption within 3 months before the study.
- Breath test indicative of smoking at study start.
- Documented lactose allergy/intolerance.
- Men whose partner is pregnant or breastfeeding cannot participate.
- Certain blood test results may not allow subjects to participate, as described in the study protocol.
For subjects with COPD:
- History of liver disease.
- Poorly controlled C OPD disease as, for example, more than 2 exacerbations of COPD per year.
- Some respiratory conditions, like for example active tuberculosis, lung cancer, pulmonary fibrosis, asthma.
- Unstable or uncontrolled cardiac disease.
- Problems with kidney function as defined in the study protocol.
- Past or current medical conditions or diseases that are not well controlled.
- Subjects are not allowed to take oral corticosteroids from 4 weeks prior to screening and for the duration of the study.
- Subjects taking medications for any chronic conditions have to be on stable doses for 4 weeks before screening and until after study treatment is finished.
- Use of short-acting inhaled bronchodilators is allowed, but subjects must be able to stop their medications several times during the study.
- Use of long-acting bronchodilators is allowed, but subjects must be able to change the schedule of their medications twice during the study.
- Participation in the study would result in loss of more than 500 mL within 3 months.
- Participation in another clinical trial with an investigational product within about 3 months before this study.
- Positive drug/alcohol screen.
- Regular use of known drugs of abuse.
- Regular alcohol consumption within 3 months before the study.
- Unable to refrain from smoking for certain periods during the study (maximum about 6 hours).
- Documented lactose allergy/intolerance.
- Men whose partner is pregnant or breastfeeding cannot participate.
- Certain blood test results may not allow subjects to participate, as described in the study protocol.
GenderAll
Age18 Years to 75 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
United Kingdom

Administrative Information

NCT Number:NCT03235726
Other Study ID Numbers
205822
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
GlaxoSmithKline
Collaborators
Not Available
Investigators
Study Director
GSK Clinical Trials
GlaxoSmithKline