Conditions: Hepatitis C Virus Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Fasted GT1 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days arm 2: Fasted GT1 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days arm 3: Fasted GT1 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days arm 4: Fasted GT3 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days arm 5: Fasted GT3 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days arm 6: Fasted GT3 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days

Interventions: intervention 1: 200 mg MK-1075 intervention 2: 400 mg MK-1075 intervention 3: 800 mg MK-1075
Intervention descriptions: intervention 1: Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days intervention 2: Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days intervention 3: Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

Protocol document: