To Assess the Effect of Food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
AstraZeneca
Study ID
NCT01974349
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • selumetinib (oral) — DRUG
    Volunteers will receive: 75 mg selumetinib oral dose in a fasted state (Treatment A) followed by a second 75 mg selumetinib oral dose in the fed state (Treatment B) with a washout period of at least 7 days between doses, or: 75 mg selumetinib oral dose in the fed state (Treatment B) followed by a second 75 mg selumetinib oral dose in the fasted state (Treatment A) with a washout period of at least 7 days between doses.

Study Details

Study to assess the effect of food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers

Key Dates

Start date
Nov 30, 2013
Status verified
Aug 2014
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

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

Arms

  • Experimental: selumetinib 75mg (oral capsule fasted)
    Volunteers will recieve selumetinib 75mg administered by mouth, as a capsule, in a fasted state.
  • Experimental: selumetinib 75mg (oral capusle fed)
    Volunteers will receive selumetinib 75mg administered by mouth, as a capsule, in a fed state.

Primary Outcome Measure

Pharmacokinetics of selumetinib and N desmethyl selumetinib, by assessment of maximum plasma concentration (Cmax) [ Time Frame: Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOverland ParkKansas--

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Research Site· Overland Park, KS

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