NCT03765671

Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients

An Open-label, Phase 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Adult Subjects With Hepatic Impairment and Adult Healthy Control Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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 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

• Hepatic Impairment
• Liver Disease
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Elafibranor	120mg oral single dose

Timeline

• Start date: 2018-12-12
• Primary completion: 2019-06-07
• Completion: 2019-06-14
• First posted: 2018-12-05
• Last updated: 2019-08-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study