A Study to Assess the Relative Bioavailability of Process Variants of Selumetinib in Healthy Male Volunteers
- Sponsor
- AstraZeneca
- Study ID
- NCT02322749
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Volunteers Bioequivalence or Bioavailability Study
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- selumetinib 75mg single dose — DRUG3 blue capsules of 25 mg given as a single dose
- selumetinib 75mg single dose — DRUG3 capsules of 25 mg given as a single dose
- selumetinib 75mg single dose — DRUG3 capsules of 25 mg given as a single dose
Study Details
A Study to assess, against a reference selumetinib capsule, if the drug levels of a variant of selumetinib capsule are comparable, and to assess how drug levels differed in another variant of Selumetinib in Healthy Male Volunteers.
Key Dates
- Start date
- Feb 28, 2015
- Status verified
- Jul 2016
- Primary completion
- Apr 30, 2015
- Completion
- Apr 30, 2015
Study Design
- Enrollment
- 48 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Treatment AAZD6244 blue reference capsules (3 x 25 mg) administered orally
- Experimental: Treatment BAZD6244 blue capsules (3 x 25 mg) Variant 1 (free base variant) administered orally
- Experimental: Treatment CAZD6244 blue capsules (3 x 25 mg) Variant 2 (vitamin E polyethylene glycol succinate \[TPGS\] variant) administered orally
Primary Outcome Measure
Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax] [ Time Frame: Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4). ]