Conditions: Hepatitis C
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: yes

Brief summary:
This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.

Detailed description:

Arms:
arm 1: Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir arm 2: Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir arm 3: Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir arm 4: Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir arm 5: Participants with severe HI administered a single 200 mg oral tablet of vaniprevir arm 6: Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir

Interventions: intervention 1: Vaniprevir 300 mg intervention 2: Vaniprevir 200 mg
Intervention descriptions: intervention 1: single dose administration of 300 mg oral tablet intervention 2: single dose administration of 200 mg oral tablet

Protocol document: