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Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients

NCT03844555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-08-13

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 participants with renal impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in severe renal impaired participants (eGFR\<15mL/mn/1.73m\^2) versus healthy participants after a single oral administration of elafibranor 120 mg

Conditions

Interventions

DRUG

Elafibranor

120mg oral single dose

Sponsors & Collaborators

  • 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
2019-02-28
Primary Completion
2020-03-15
Completion
2020-03-21

Countries

  • France
  • Romania

Study Locations

More Related Trials

Entities

Diseases

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 NCT03844555 on ClinicalTrials.gov