drugset / Trial / NCT03765671
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
Non-randomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2018-12-12
- Primary completion
- 2019-06-07
- Completion
- 2019-06-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elafibranor | Small molecule | 120 mg | Oral |