Conditions: Hepatic Impairment
Keywords: Healthy volunteer Alectinib Hepatic impairment
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: yes

Brief summary:
This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokinetics of alectinib.

Detailed description:

Arms:
arm 1: Participants with moderate hepatic impairment (based on Child-Pugh score) will receive alectinib at a single oral dose of 300 milligrams (mg) on Day 1. arm 2: Participants with severe hepatic impairment (based on Child-Pugh score) will receive alectinib at a single oral dose of 300 mg on Day 1. arm 3: Participants with normal hepatic function will receive alectinib at a single oral dose of 300 mg on Day 1.

Interventions: intervention 1: Alectinib
Intervention descriptions: intervention 1: Participants will receive alectinib as per the dosage schedule mentioned in arm description.

Protocol document: