NCT02461563

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

A Multiple-Dose Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of MK-1075 in GT3 and GT1 HCV Infected Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	200 mg MK-1075	Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
DRUG	400 mg MK-1075	Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
DRUG	800 mg MK-1075	Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

Timeline

• Start date: 2015-06-23
• Primary completion: 2015-12-23
• Completion: 2015-12-23
• First posted: 2015-06-03
• Last updated: 2018-11-13
• Results posted: 2018-11-13