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

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
AstraZeneca
Study ID
NCT02056392
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Selumetinib — DRUG
    Volunteers will receive 75 mg selumetinib oral dose (Treatment A)
  • Moxifloxacin — DRUG
    Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)
  • selumetinib placebo — DRUG
    Volunteers will receive selumetinib placebo oral dose (Treatment C)

Study Details

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

Key Dates

Start date
Mar 31, 2014
Status verified
Sep 2015
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Selumetinib 75mg
    Volunteers will receive selumetinib 75mg administered by mouth, as a capsule
  • Active Comparator: Moxifloxacin 400 mg
    Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule
  • Placebo Comparator: Selumetinib 75mg placebo
    Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule.

Primary Outcome Measure

Change From Baseline in QTcF [ Time Frame: 30 min ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOverland ParkKansas--

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Research Site· Overland Park, KS

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