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A Study to Assess the Relative Bioavailability of Process Variants of Selumetinib in Healthy Male Volunteers

NCT02322749 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-08-31

Study results available
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Summary

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.

Conditions

  • Healthy Volunteers Bioequivalence or Bioavailability Study

Interventions

DRUG

selumetinib 75mg single dose

3 blue capsules of 25 mg given as a single dose

DRUG

selumetinib 75mg single dose

3 capsules of 25 mg given as a single dose

DRUG

selumetinib 75mg single dose

3 capsules of 25 mg given as a single dose

Sponsors & Collaborators

Principal Investigators

  • Olufeyikemi Oluwayi, MBChB · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT02322749 on ClinicalTrials.gov