NCT03866369

Multiple Ascending Dose Phase I Study in Order to Define Lanifibranor (IVA337) Supra-thjerapeutic Dose

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Inventiva Pharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Moxifloxacin	Single oral dose at D-8
DRUG	Placebo	Single oral dose at D-1
DRUG	Lanifibranor	Single daily oral dose during 14 days
DRUG	Placebo	Single daily oral dose during 14 days

Timeline

• Start date: 2019-01-17
• Primary completion: 2019-08-27
• Completion: 2019-08-27
• First posted: 2019-03-07
• Last updated: 2019-11-01

Locations

1 site across 1 country: Germany