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HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subjects

NCT04252417 ↗

Phase 1 Terminated 15 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 hepatic impaired patients and healthy subjects with normal hepatic function. The planned enrollment is 16 subjects (8 impaired patients and 8 healthy subjects).

Timeline

Start
2019-10-11
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

EvaluationDrugModalityDoseRoute
Comparator Biotin Small molecule 100 mg Oral

Indications

No indication recorded.