Conditions: Long QT Syndrome
Keywords: Hepatic Impairment
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 49
Healthy volunteers: yes

Brief summary:
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral eleclazine and its metabolite, GS-623134, in participants with normal and impaired hepatic function. Participants in the healthy control group will be matched to participants with impaired hepatic function by age (± 5 years), gender, and body mass index (± 10%).

Detailed description:

Arms:
arm 1: Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). arm 2: Participants with severe hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets). arm 3: Participants with mild hepatic impairment and matched healthy controls will receive a single dose of eleclazine 30 mg (5 x 6 mg tablets).

Interventions: intervention 1: Eleclazine
Intervention descriptions: intervention 1: Eleclazine tablets administered orally

Protocol document: