Study identifier:D1532C00071
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Solid tumours
Phase 1
Yes
Selumetinib, Moxifloxacin, selumetinib placebo
Male
54
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Sept 2015 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Selumetinib 75mg Volunteers will receive selumetinib 75mg administered by mouth, as a capsule | Drug: Selumetinib Volunteers will receive 75 mg selumetinib oral dose (Treatment A) Other Name: AZD6244 |
Active Comparator: Moxifloxacin 400 mg Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule | Drug: Moxifloxacin Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B) Other Name: Avelox® |
Placebo Comparator: Selumetinib 75mg placebo Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule. | Drug: selumetinib placebo Volunteers will receive selumetinib placebo oral dose (Treatment C) Other Name: AZD6244 placebo |