First-In-Human PainCart Study for STR-324

ID: NCT03430232
Status: Recruiting
Phase: Phase 1
Start Date: February 20, 2018
First Submitted: January 19, 2018
Last Updated: February 23, 2018
Results: N/A
Organization: Stragen France
Sponsors & Collaborators: Stragen France
Location: Netherlands
Conditions: Pain
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Study Description

Brief Summary

This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part, ascending doses study to investigate the safety, tolerability and efficacy of STR-324 infusions in healthy volunteers.

Detailed Description

Part I : ascending doses of short lasting infusion Part II : ascending doses of long lasting infusion
Condition or disease Intervention/treatment Phase

Pain

Drug: Placebo
Other Names
Drug: STR-324 Dose Level 1
Other Names
Drug: STR-324 Dose Level 2
Other Names
Drug: STR-324 Dose Level 3
Other Names
Drug: STR-324 Dose Level 4
Other Names
Drug: STR-324 Dose Level 5
Other Names
Drug: STR-324 Dose Level 6
Other Names
Drug: STR-324 Dose Level 7
Other Names
Drug: STR-324 Dose Level 8
Other Names
Drug: STR-324 Dose Level A
Other Names
Drug: STR-324 Dose Level B
Other Names
Drug: STR-324 Dose Level C
Other Names
Drug: Placebo
Other Names
Phase 1

Tracking Information

First Submitted DateJanuary 19, 2018
Last Update Posted DateFebruary 23, 2018
Actual Start DateFebruary 20, 2018
Anticipated Completion DateSeptember 01, 2018
Actual Primary Completion DateSeptember 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Safety and tolerability: number of subjects who experience (serious) treatment emergent adverse events, potential clinically changes in vital signs, ECG, holter, physical examinations, laboratory tests and urine production [Time Frame: Day 7 (+/- 2 days) post dosing]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Parts I and II: Maximum plasma concentration (Cmax) [Time Frame: Up to 24 hours for Part I and up to 56 hours for Part II]

  • Parts I and II:Time to maximum plasma concentration (Tmax) [Time Frame: Up to 24 hours for Part I and up to 56 hours for Part II]

  • Parts I and II: Area under the plasma concentration-time curve from zero to infinity(AUC0-inf) [Time Frame: Up to 24 hours for Part I and up to 56 hours for Part II]

  • Parts I and II: Area under the plasma concentration-time curve from zero to the last measured concentration above the limit of quantification (AUC0-last) [Time Frame: Up to 24 hours for Part I and up to 56 hours for Part II]

  • Parts I and II: Terminal disposition rate constant (λz) with the respective half-life (t½) [Time Frame: Up to 24 hours for Part I and up to 56 hours for Part II]

  • Parts I and II: Amount excreted in urine in 24 hours [Time Frame: Up to 24 hours for Part I and up to 56 hours for Part II]

  • Parts I and II: Thermal Pain [Time Frame: Up to 5 hours for part I and up to 56 hours for part II]

  • Parts I and II: Electrical pain Stair and Burst [Time Frame: Up to 5 hours for part I and up to 56 hours for part II]

  • Parts I and II: Pressure Pain [Time Frame: Up to 5 hours for part I and up to 56 hours for part II]

  • Parts I and II: Cold Pressor [Time Frame: Up to 5 hours for part I and up to 56 hours for part II]

  • Parts I and II: Conditioned Pain Modulation Response (change from electrical stair pre- and post-cold pressor) [Time Frame: Up to 5 hours for part I and up to 56 hours for part II]

  • Parts I and II: Visual Analogue Scale Bond & Lader [Time Frame: Up to 5 hours for part I and up to 56 hours for part II]

  • Parts I and II: Visual Analogue Scale Bowdle [Time Frame: Up to 5 hours for part I and up to 56 hours for part II]

  • Part II only: Saccadic eye movement [Time Frame: Up to 56 hours]

  • Part II only: Smooth pursuit eye movement [Time Frame: Up to 56 hours]

  • Part II only: Adaptive tracking [Time Frame: Up to 56 hours]

  • Part II only: Body sway [Time Frame: Up to 56 hours]

  • Part II only: N-Back [Time Frame: Up to 56 hours]

  • Part II only: Pharmaco-EEG: power [Time Frame: Up to 56 hours]

  • Part II only: Pupillometry [Time Frame: Up to 56 hours]

  • Part II only: 49-item Addiction Center Research Inventory [Time Frame: Up to 60 hours]

  • Part II only: Bowel Function Index [Time Frame: Up to day 7]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleFirst-In-Human PainCart Study for STR-324
Official TitleA First-in-Human, Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STR-324 in Healthy Subjects
Brief Summary

This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part, ascending doses study to investigate the safety, tolerability and efficacy of STR-324 infusions in healthy volunteers.

Detailed Description

Part I : ascending doses of short lasting infusion Part II : ascending doses of long lasting infusion

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
78
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Pain
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Placebo

Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%

Other Names
Drug: STR-324 Dose Level 1

Short infusion of a solution for intravenous administration

Other Names
Drug: STR-324 Dose Level 2

Short infusion of a solution for intravenous administration

Other Names
Drug: STR-324 Dose Level 3

Short infusion of a solution for intravenous administration

Other Names
Drug: STR-324 Dose Level 4

Short infusion of a solution for intravenous administration

Other Names
Drug: STR-324 Dose Level 5

Short infusion of a solution for intravenous administration

Other Names
Drug: STR-324 Dose Level 6

Short infusion of a solution for intravenous administration

Other Names
Drug: STR-324 Dose Level 7

Short infusion of a solution for intravenous administration

Other Names
Drug: STR-324 Dose Level 8

Short infusion of a solution for intravenous administration

Other Names
Drug: STR-324 Dose Level A

Long infusion of a solution for intravenous administration

Other Names
Drug: STR-324 Dose Level B

Long infusion of a solution for intravenous administration

Other Names
Drug: STR-324 Dose Level C

Long infusion of a solution for intravenous administration

Other Names
Drug: Placebo

Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%

Other Names
Study Groups/Cohorts
Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.

Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.

Part II (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level A or placebo as a long infusion according to randomization.

Part II (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level B or placebo as a long infusion according to randomization.

Part II (Panel 3): STR-324 or placebo
Subjects will receive STR-324 dose level C or placebo as a long infusion according to randomization.

Study Arms
Experimental Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug : Placebo
Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%

Experimental Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 1
Short infusion of a solution for intravenous administration

Experimental Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 3
Short infusion of a solution for intravenous administration

Experimental Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 5
Short infusion of a solution for intravenous administration

Experimental Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 7
Short infusion of a solution for intravenous administration

Experimental Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 8
Short infusion of a solution for intravenous administration

Experimental Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 6
Short infusion of a solution for intravenous administration

Experimental Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 4
Short infusion of a solution for intravenous administration

Experimental Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 2
Short infusion of a solution for intravenous administration

Experimental Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug : Placebo
Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%

Experimental Part II (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level A or placebo as a long infusion according to randomization.
Drug : STR-324 Dose Level A
Long infusion of a solution for intravenous administration

Experimental Part II (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level A or placebo as a long infusion according to randomization.
Drug : Placebo
Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%

Experimental Part II (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level B or placebo as a long infusion according to randomization.
Drug : Placebo
Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%

Experimental Part II (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level B or placebo as a long infusion according to randomization.
Drug : STR-324 Dose Level B
Long infusion of a solution for intravenous administration

Experimental Part II (Panel 3): STR-324 or placebo
Subjects will receive STR-324 dose level C or placebo as a long infusion according to randomization.
Drug : STR-324 Dose Level C
Long infusion of a solution for intravenous administration

Experimental Part II (Panel 3): STR-324 or placebo
Subjects will receive STR-324 dose level C or placebo as a long infusion according to randomization.
Drug : Placebo
Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%

Arm Intervention/Treatment
Experimental Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug : Placebo
Experimental Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 1
Experimental Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 3
Experimental Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 5
Experimental Part I (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level 1, 3, 5, 7 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 7
Experimental Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 8
Experimental Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 6
Experimental Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 4
Experimental Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug : STR-324 Dose Level 2
Experimental Part I (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level 2, 4, 6, 8 or placebo as a short infusion according to randomization.
Drug : Placebo
Experimental Part II (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level A or placebo as a long infusion according to randomization.
Drug : STR-324 Dose Level A
Experimental Part II (Panel 1): STR-324 or placebo
Subjects will receive STR-324 dose level A or placebo as a long infusion according to randomization.
Drug : Placebo
Experimental Part II (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level B or placebo as a long infusion according to randomization.
Drug : Placebo
Experimental Part II (Panel 2): STR-324 or placebo
Subjects will receive STR-324 dose level B or placebo as a long infusion according to randomization.
Drug : STR-324 Dose Level B
Experimental Part II (Panel 3): STR-324 or placebo
Subjects will receive STR-324 dose level C or placebo as a long infusion according to randomization.
Drug : STR-324 Dose Level C
Experimental Part II (Panel 3): STR-324 or placebo
Subjects will receive STR-324 dose level C or placebo as a long infusion according to randomization.
Drug : Placebo

Recruitment Information

Recruitment Status:Recruiting
Enrollment78
Completion DateSeptember 01, 2018
Eligibility Criteria: Inclusion Criteria:
- Signed informed consent prior to any study-mandated procedure
- Healthy male subjects, 18 to 45 years of age, inclusive at screening.
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
- All males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment.
- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Exclusion Criteria:
- Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
- Subject with clinically significant abnormalities in blood pressure, heart rate, ECG recording and laboratory parameters
- Abnormal renal function (eGFR (MDRD) < 60 mL/min/1.73m2).
- Previous history of seizures or epilepsy.
- Acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before the first study day.
- Positive Hepatitis B surface antigen (HBsAg), Hepatitis B antibodies, Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
- Use of any medications (prescription or over-the-counter [OTC]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer).
- Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer).
- Participation in an investigational drug or device study within 3 months prior to first dosing.
- History of abuse of addictive substances or current use of substances (alcohol, illegal substances)
- Positive test for drugs of abuse or alcohol breath test at screening or pre-dose.
- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
- Loss or donation of blood over 500 mL within three months prior to screening
- Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold or pain
GenderMale
Age18 Years to 45 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
Netherlands

Administrative Information

NCT Number:NCT03430232
Other Study ID Numbers
STR-324-CL-039
2014-002402-21
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
Stragen France
Collaborators
Not Available
Investigators
Not Available