A Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define Lanifibranor (IVA337) Supra-therapeutic Dose in a Multiple Dosing Regimen
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Subjects
- Sponsor
- Inventiva Pharma
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Number of Adverse events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The study will be a double-blind, randomized, placebo-controlled, multiple ascending dose study with lanifibranor. The study will consist of up to 3 cohorts of 12 subjects each; therefore, approximately 36 subjects will be included in this study.
Detailed Description
All subject will receive first a single dose of 400 mg moxifloxacin, under open-label fasting conditions at Day -8 (assay sensitivity). Following, all subjects also will receive a dose of placebo under open-label fasting conditions at D-1. In the morning of Day 1, subjects will be randomized to either the investigational medicinal product (IMP) or placebo (3:1). The treatment phase last 14 days and the end of study visit will occurs within 5 to 9 days after the last dose of IMP or placebo (or at early termination) A staggered dose approach will be applied within each subjects cohort with 48 hours of delay between subcohorts. A sefty review committe (SRC) will review after each cohorts all available safety and PK data under blinded conditions and conclude the safety and tolerability of the dose level before proceeding to the next dose level.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo to Match
Intervention: Placebo
Experimental
IMP Under investigation
Intervention: Moxifloxacin
Experimental
IMP Under investigation
Intervention: Placebo
Experimental
IMP Under investigation
Intervention: Lanifibranor
Placebo to Match
Intervention: Moxifloxacin
Outcomes
Primary Outcomes
Number of Adverse events
Time Frame: From Baseline up to 15 days
Number of abnormal Clinical laboratory tests (chemistry, hematology, urinalysis)
Time Frame: From Baseline up to 15 days
Number of abnormal Vital signs (blood pressure, pulse) and physical exams
Time Frame: From Baseline up to 15 days
Number of abnormal 12-lead digital electrocardiograms parameters (Heart rate, QT/QTc interval, PR interval, QRS interval, RR interval) change from baseline
Time Frame: From Baseline up to 15 days
Secondary Outcomes
- Maximum plasma concentration (Cmax) of lanifibranor and its metabolites(15 days)
- Time of maximum plasma concentration (Tmax) of lanifibranor and its metabolites(15 days)
- Number of Cardiovascular safety events(From Baseline up to 15 days)
- Area under the concentration-time curve (AUC0-t) of lanifibranor and its metabolites(From Baseline up to 15 days)