To assess the effect of Itraconazole and Fluconazole on the pharmacokinetics of Selumetinib in Healthy Male Volunteers
Study identifier:D1532C00083
ClinicalTrials.gov identifier:NCT02093728
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open-label, Single-center Study to Assess the Effect of the CYP3A4 Inhibitor Itraconazole and the CYP2C19 Inhibitor Fluconazole on the Pharmacokinetics of a 25 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Volunteers aged 18 to 45 years
Medical condition
Solid tumours
Phase
Phase 1
Healthy volunteers
Yes
Study drug
selumetinib, itraconazole, fluconazole
Sex
All
Actual Enrollment
26
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Apr 2014
Primary Completion Date: 01 Jun 2014
Study Completion Date: 01 Jun 2014
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Feb 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 | Drug: selumetinib Volunteers will recieve single oral dose of 25mg selumetinib in sequence 1, treatment A Other Name: (AZD6244; ARRY-142866) ( Hyd-Sulfate) Drug: itraconazole Volunteers will receive oral doses of itraconazole 200 mg twice daily on Day 1 to Day 7 in sequence 1 treatment B: Drug: itraconazole 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. Drug: selumetinib Volunteers willl recieve a single oral dose of 25 mg selumetinib (4 hours fasted state) on Day 8; sequence 1 treatment C. Other Name: (AZD6244; ARRY-142866) ( Hyd-Sulfate) |
| 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. | Drug: selumetinib Volunteers will recieve single oral dose of 25mg selumetinib in sequence 2, treatment A. Other Name: (AZD6244; ARRY-142866) ( Hyd-Sulfate) Drug: fluconazole 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. Drug: fluconazole 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 Drug: selumetinib Volunteers will receive a single dose of 25mg selumetinib (4 hours fasted state) on Day 8; sequence 2 treatment E |
Contacts
Investigators
Principal Investigator
David R Mathews
Quintiles 6700 W 115th Street, Kansas, US
