At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
selumetinib 75mg single dose +1 moredrug
Likely dose
selumetinib 75mg single dosefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Selumetinib With Respect to an Intravenous Microdose of [14C] Selumetinib in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating selumetinib 75mg single dose and [14C] selumetinib IV solution for Healthy Volunteers Bioavailability Study. Completed, enrolled 21 participants across 1 site.
Detailed Summary
To assess the absolute bioavailability of oral selumetinib in healthy male volunteers
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers Bioavailability Study
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartOct 2014
Primary CompletionNov 2014
TodayJul 2026
First PostedSep 12, 2014
Enrollment StartOct 1, 2014
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.8 years ago
Interventions
selumetinib 75mg single dosedrug
3 capsules of 25 mg given as a single dose
[14C] selumetinib IV solutionother
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