To assess the pharmacokinetics, safety and tolerability of selumetinib in patients with hepatic impairment and healthy subjects

Study identifier:D1532C00082

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-label, Comparative Study to Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY-142886) (Hyd-Sulfate) following Single Oral Dosing to Healthy Subjects and to Subjects with Mild, Moderate, and Severe Hepatic Impairment

Medical condition

Solid Tumors

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Selumetinib 50mg, Selumetinib 25mg

Sex

All

Actual Enrollment

32

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 01 Mar 2014
Primary Completion Date: 01 Nov 2014
Study Completion Date: 01 Nov 2014

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Jun 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria