drugset / Trial / NCT04252430
RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects
Non-randomizedParallel-groupQuadruple-blindOther
Summary
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in renal impaired patients and healthy subjects with normal renal function. The planned enrollment is 36 subjects (18 impaired patients and 18 healthy subjects).
Timeline
- Start
- 2019-10-09
- Primary completion
- 2020-03-17
- Completion
- 2020-03-17
Outcome
Outcome not reported
Stopped: “Due to other phase 3 trial failure to meet primary endpoint”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Biotin | Small molecule | 100 mg | Oral |