drugset / Trial / NCT02461563

A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)

NCT02461563 ↗

Phase 1 Completed 12 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL) reduction is at least 3 log10 IU/mL as compared to baseline following multiple dose oral administration of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected participants.

Timeline

Start
2015-06-23
Primary completion
2015-12-23
Completion
2015-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-1075 Unknown 200 mg Oral
Subject MK-1075 Unknown 400 mg Oral
Subject MK-1075 Unknown 800 mg Oral