drugset / Trial / NCT03844555
Elafibranor Pharmacokinetic Parameters in Renal 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 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
Timeline
- Start
- 2019-02-28
- Primary completion
- 2020-03-15
- Completion
- 2020-03-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elafibranor | Small molecule | 120 mg | Oral |