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

NCT02056392 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-11-09

Study results available
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Summary

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

Conditions

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Scott Rasmussen, MD · Quintiles 6700 W 115th Street, Kansas, US

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02056392 on ClinicalTrials.gov