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A Study to Assess the Absolute Bioavailability of Oral Selumetinib in Healthy Male Volunteers.

NCT02238782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-04-05

Study results available
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Summary

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

Conditions

  • Healthy Volunteers Bioavailability Study

Interventions

DRUG

selumetinib 75mg single dose

3 capsules of 25 mg given as a single dose

OTHER

[14C] selumetinib IV solution

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

Sponsors & Collaborators

Principal Investigators

  • Stuart Mair · Quotient Clinical Ltd

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02238782 on ClinicalTrials.gov