NCT03844555

Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients

Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of Elafibranor 120 mg in Renal Impaired Patients and Healthy Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

• Renal Impairment
• Renal Insufficiency
• Kidney Diseases
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Elafibranor	120mg oral single dose

Timeline

• Start date: 2019-02-28
• Primary completion: 2020-03-15
• Completion: 2020-03-21
• First posted: 2019-02-18
• Last updated: 2020-08-13

Locations

2 sites across 2 countries: France, Romania