MedTrace Logo

Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients

NCT03765671 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-22

No results posted yet for this study

Summary

This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe according to Child-Pugh categories) versus healthy participants after a single oral administration of elafibranor 120 mg.

Conditions

Interventions

DRUG

Elafibranor

120mg oral single dose

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • University of Miami

    collaborator OTHER

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Pascal BIRMAN, MD · Genfit

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2019-06-07
Completion
2019-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03765671 on ClinicalTrials.gov