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

NCT03866369 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-11-01

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Inventiva Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2019-08-27
Completion
2019-08-27

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866369 on ClinicalTrials.gov