Healthy Subjects Clinical Trial
Official title:
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
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.
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.
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