Conditions: Hepatic Insufficiency
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.

Detailed description:

Arms:
arm 1: Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale arm 2: Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale arm 3: Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale arm 4: Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight

Interventions: intervention 1: Elbasvir
Intervention descriptions: intervention 1: None

Protocol document: