First-In-Human PainCart Study for STR-324

Pain Clinical Trial

Official title:

A First-in-Human, Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STR-324 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430232
• Other study ID #: STR-324-CL-039
• Secondary ID: 2014-002402-21
• Status: Completed
• Phase: Phase 1
• Start date: February 20, 2018
• Est. completion date: November 7, 2018

Study information

• Verified date: December 2018
• Source: Stragen France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 7, 2018
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Placebo
Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%
• STR-324 Dose Level 1
Short infusion of a solution for intravenous administration
• STR-324 Dose Level 2
Short infusion of a solution for intravenous administration
• STR-324 Dose Level 3
Short infusion of a solution for intravenous administration
• STR-324 Dose Level 4
Short infusion of a solution for intravenous administration
• STR-324 Dose Level 5
Short infusion of a solution for intravenous administration
• STR-324 Dose Level 6
Short infusion of a solution for intravenous administration
• STR-324 Dose Level 7
Short infusion of a solution for intravenous administration
• STR-324 Dose Level 8
Short infusion of a solution for intravenous administration
• STR-324 Dose Level A
Long infusion of a solution for intravenous administration
• STR-324 Dose Level B
Long infusion of a solution for intravenous administration
• STR-324 Dose Level C
Long infusion of a solution for intravenous administration
• Placebo
Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%

Locations

Country	Name	City	State
Netherlands	CHDR	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Stragen France

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Day 7 (+/- 2 days) post dosing
Secondary	Parts I and II: Maximum plasma concentration (Cmax)		Up to 24 hours for Part I and up to 52 hours for Part II
Secondary	Parts I and II:Time to maximum plasma concentration (Tmax)		Up to 24 hours for Part I and up to 52 hours for Part II
Secondary	Parts I and II: Area under the plasma concentration-time curve from zero to infinity(AUC0-inf)		Up to 24 hours for Part I and up to 52 hours for Part II
Secondary	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)		Up to 24 hours for Part I and up to 52 hours for Part II
Secondary	Parts I and II: Terminal disposition rate constant (?z) with the respective half-life (t½)		Up to 24 hours for Part I and up to 52 hours for Part II
Secondary	Parts I and II: Amount excreted in urine in 24 hours		Up to 24 hours for Part I and up to 72 hours for Part II
Secondary	Parts I and II: Thermal Pain		Up to 5 hours for part I and up to 56 hours for part II
Secondary	Parts I and II: Electrical pain Stair and Burst		Up to 5 hours for part I and up to 56 hours for part II
Secondary	Parts I and II: Pressure Pain		Up to 5 hours for part I and up to 56 hours for part II
Secondary	Parts I and II: Cold Pressor		Up to 5 hours for part I and up to 56 hours for part II
Secondary	Parts I and II: Conditioned Pain Modulation Response (change from electrical stair pre- and post-cold pressor)		Up to 5 hours for part I and up to 56 hours for part II
Secondary	Parts I and II: Visual Analogue Scale Bond & Lader		Up to 5 hours for part I and up to 56 hours for part II
Secondary	Parts I and II: Visual Analogue Scale Bowdle		Up to 5 hours for part I and up to 56 hours for part II
Secondary	Part II only: Saccadic eye movement		Up to 56 hours
Secondary	Part II only: Smooth pursuit eye movement		Up to 56 hours
Secondary	Part II only: Adaptive tracking		Up to 56 hours
Secondary	Part II only: Body sway		Up to 56 hours
Secondary	Part II only: N-Back		Up to 56 hours
Secondary	Part II only: Pharmaco-EEG: power		Up to 56 hours
Secondary	Part II only: Pupillometry		Up to 56 hours
Secondary	Part II only: 49-item Addiction Center Research Inventory		Up to 60 hours
Secondary	Part II only: Bowel Function Index		Up to day 7
Secondary	Part II - Groups 2 and 3 only: Thermal pain (Normal skin and erythema skin - UVB)		Up to 24 hours