Conditions: Hepatic Impairment Liver Diseases Digestive System Diseases
Keywords: Hepatic Impairment Pharmacokinetics Pharmacodynamics
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: yes

Brief summary:
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers with normal hepatic function.

Detailed description:

Arms:
arm 1: All subjects with mild hepatic impairment received a single 50 mg oral dose of IDN-6556 arm 2: All subjects with moderate hepatic impairment received a single 50 mg oral dose of IDN-6556 arm 3: All subjects with severe hepatic impairment received a single 50 mg oral dose of IDN-6556 arm 4: All healthy volunteers subjects received a single 50 mg oral dose of IDN-6556

Interventions: intervention 1: IDN-6556
Intervention descriptions: intervention 1: None

Protocol document: