To Assess the Effect of Rifampicin on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
AstraZeneca
Study ID
NCT02046850
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 a single oral dose of 75 mg selumetinib on day 1 (Treatment A).
  • rifampicin — DRUG
    Volunteers will receive single, daily, oral doses of 600 mg rifampicin on Days 4 to 11 (Treatment B).
  • selumetinib — DRUG
    On day 12 volunteers will receive a single oral dose of 75 mg selumetinib (Treatment C).
  • rifampicin — DRUG
    On day 12 volunteers will receive a single oral dose of 600 mg rifampicin. Once daily rifampicin administrations will continue through to Day 14 (Treatment C).

Study Details

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

Key Dates

Start date
Feb 28, 2014
Status verified
Apr 2014
Primary completion
Apr 30, 2014
Completion
Apr 30, 2014

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: selumetinib 75mg.
    Volunteers will receive selumetinib 75mg administered by mouth, as a capsule
  • Other: rifampicin 600mg.
    Volunteers will receive rifampicin 600mg administered by mouth, as a capsule
  • Experimental: selumetinib 75mg and rifampicin 600mg
    Volunteers will receive selumetinib 75mg and rifampicin 600mg, by mouth, as a capsule

Primary Outcome Measure

Pharmacokinetics of selumetinib by assessment of area under the plasma concentration-time curve from time zero to infinity (AUC) [ Time Frame: Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOverland ParkKansas--

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