To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
AstraZeneca
Study ID
NCT02093728
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • selumetinib — DRUG
    Volunteers will recieve single oral dose of 25mg selumetinib in sequence 1, treatment A
  • itraconazole — DRUG
    Volunteers will receive oral doses of itraconazole 200 mg twice daily on Day 1 to Day 7 in sequence 1 treatment B:
  • itraconazole — DRUG
    Volunteers will recieve a single morning dose of 200mg itraconazole on Day 8 and twice daily doses of 200mg itraconazole on Day 8 to Day 11; sequence 1 treatment C.
  • selumetinib — DRUG
    Volunteers willl recieve a single oral dose of 25 mg selumetinib (4 hours fasted state) on Day 8; sequence 1 treatment C.
  • selumetinib — DRUG
    Volunteers will recieve single oral dose of 25mg selumetinib in sequence 2, treatment A.
  • fluconazole — DRUG
    Volunteers will recieve a single dose of 400 mg fluconazole on Day 1 and daily doses of 200 mg fluconazole on Day 2 to Day 7; sequence 2 treatment D.
  • fluconazole — DRUG
    Volunteers will receive a morning dose of 200mg fluconazole on Day 8 and daily doses of 200mg fluconazole on Day 8 to Day 11; sequence 2 treatment E
  • selumetinib — DRUG
    Volunteers will receive a single dose of 25mg selumetinib (4 hours fasted state) on Day 8; sequence 2 treatment E

Study Details

Study to assess the effect of Itraconazole and Fluconazole on the pharmacokinetics of Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Male Volunteers

Key Dates

Start date
Apr 30, 2014
Status verified
Jun 2015
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: selumetinib; itraconazole; selumetinib + itraconazole
    Volunteers will receive selumetinib 25mg alone; itraconazole 200mg pre-dosing; selumetinib 25mg and itraconazole 200mg; all adminstered by mouth as a capsule
  • Experimental: selumetinib; fluconazole; selumetinib + fluconazole
    Volunteers will receive selumetinib 25mg alone administered by mouth as a capsule; fluconazole 400mg and fluconazole 200mg pre-dosing, administered by mouth as a tablet; selumetinib 25mg and fluconazole 200mg.

Primary Outcome Measure

Pharmacokinetics of selumetinib and N-desmethyl selumetinib by assessment of area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) [ 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, 48, 72 and 96 hours post dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOverland ParkKansas--

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Research Site· Overland Park, KS

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