At a glance
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A Multiple-Dose Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of MK-1075 in GT3 and GT1 HCV Infected Patients
In Brief
A Phase 1 clinical trial evaluating 200 mg MK-1075, 400 mg MK-1075, and 1 other intervention for Hepatitis C Virus Infection. Completed, enrolled 12 participants.
Detailed 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.
Study Details
Timeline
Interventions
Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days