Conditions: Healthy Volunteers Bioavailability Study
Keywords: bioavailability pharmacokinetics I phase AZD6244 cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: yes

Brief summary:
To assess the absolute bioavailability of oral selumetinib in healthy male volunteers

Detailed description:

Arms:
arm 1: 3 capsules of 25 mg administered orally

Interventions: intervention 1: selumetinib 75mg single dose intervention 2: [14C] selumetinib IV solution
Intervention descriptions: intervention 1: 3 capsules of 25 mg given as a single dose intervention 2: single, 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

Protocol document: