A Study to Assess the Absolute Bioavailability of Oral Selumetinib in Healthy Male Volunteers.
- Sponsor
- AstraZeneca
- Study ID
- NCT02238782
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Volunteers Bioavailability Study
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- selumetinib 75mg single dose — DRUG3 capsules of 25 mg given as a single dose
- [14C] selumetinib IV solution — OTHERsingle, radiolabeled, IV (infused), microdose (80 μg) of \[14C\] selumetinib, infused using a syringe pump as a 15-minute infusion, administered 1h 15 min after receiving the oral dose
Study Details
To assess the absolute bioavailability of oral selumetinib in healthy male volunteers
Key Dates
- Start date
- Oct 31, 2014
- Status verified
- Mar 2016
- Primary completion
- Nov 30, 2014
- Completion
- Nov 30, 2014
Study Design
- Enrollment
- 21 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: selumetinib 75mg single dose3 capsules of 25 mg administered orally
Primary Outcome Measure
Absolute Bioavailability [ Time Frame: 0 to 72 hours post-dose ]