drugset / Trial / NCT04252430

RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects

NCT04252430

Phase 1 Terminated 24 enrolled MedDay Pharmaceuticals SA Eurofins Optimed · collab
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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Biotin Small molecule 100 mg Oral