To assess the effects of single oral dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc interval in healthy male volunteers

Study identifier:D1532C00071

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Double-blind (Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Aged 18 to 45 years

Medical condition

Solid tumours

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Selumetinib, Moxifloxacin, selumetinib placebo

Sex

Male

Actual Enrollment

54

Study type

Interventional

Age

18 Years - 45 Years

Date

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

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Sept 2015 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria