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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Moxifloxacin; Drug: Placebo; Drug: Lanifibranor

• Registration Number: NCT03866369
• Lead Sponsor: Inventiva Pharma

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.

Study Timeline

• Study Start: 2019-01-17
• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-07
• Primary Completion: 2019-08-27
• Study Completion: 2019-08-27
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo to Match	Placebo	-
Experimental	Moxifloxacin	IMP Under investigation
Experimental	Placebo	IMP Under investigation
Experimental	Lanifibranor	IMP Under investigation
Placebo to Match	Moxifloxacin	-

Primary Outcome Measures

Name	Time	Method
Number of abnormal Clinical laboratory tests (chemistry, hematology, urinalysis)	From Baseline up to 15 days
Number of Adverse events	From Baseline up to 15 days
Number of abnormal Vital signs (blood pressure, pulse) and physical exams	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	From Baseline up to 15 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Parexel International GmbH; 🇩🇪 Berlin, Germany