To assess the effect of Rifampicin on the pharmacokinetics of Selumetinib in Healthy Male Volunteers

Study identifier:D1532C00085

ClinicalTrials.gov identifier:NCT02046850

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I Open-label, Single-center Study to Assess the Effect of the CYP3A4 inducer Rifampicin on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Volunteers aged 18 to 45 years

Medical condition

Solid tumours

Phase

Phase 1

Healthy volunteers

Yes

Study drug

selumetinib, rifampicin

Sex

Male

Actual Enrollment

47

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Feb 2014
Primary Completion Date: 01 Apr 2014
Study Completion Date: 01 Apr 2014

Study design

Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Feb 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria