To assess the pharmacokinetics, safety and tolerability of selumetinib in renal impaired subjects and healthy subjects

Study identifier:D1532C00081

ClinicalTrials.gov identifier:NCT02063204

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open label Comparative Study of the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY 142886) (Hyd Sulfate) following a Single Oral Dose in Subjects with Renal Impairment and Healthy Subjects

Medical condition

Solid tumours

Phase

Phase 1

Healthy volunteers

Yes

Study drug

selumetinib

Sex

All

Actual Enrollment

24

Study type

Interventional

Age

18 Years - 150 Years

Date

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

Study design

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

Verification:

Verified 01 Feb 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria