NCT02056392

To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Study to assess the effect of Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), on QTc interval in healthy male volunteers.

Detailed description

A 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

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	Selumetinib	Volunteers will receive 75 mg selumetinib oral dose (Treatment A)
DRUG	Moxifloxacin	Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)
DRUG	selumetinib placebo	Volunteers will receive selumetinib placebo oral dose (Treatment C)

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-02-06
• Last updated: 2015-11-09
• Results posted: 2015-11-09

Locations

1 site across 1 country: United States