Conditions: Solid Tumors
Keywords: Phase I, healthy, pharmacokinetic, hepatic impairment
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: yes

Brief summary:
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.

Detailed description:
An open label study to assess the pharmcokinetics, safety and tolerability of a single dose of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.

Arms:
arm 1: Healthy volunteers (HV) arm 2: Mild (Child Pugh A) hepatic impaired patients arm 3: Moderate (Child Pugh B) hepatic impaired patients arm 4: Severe (Child Pugh C) hepatic impairment patients

Interventions: intervention 1: Selumetinib 50mg intervention 2: Selumetinib 25mg
Intervention descriptions: intervention 1: HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1 intervention 2: Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1

Protocol document: