Study evaluating absorption, distribution, metabolism and excretion (ADME) of single dose [14C] selumetinib in volunteers

Study identifier:D1532C00077

ClinicalTrials.gov identifier:NCT01931761

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Single-centre, Non-randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-selumetinib in Healthy Male Volunteers

Medical condition

Solid tumours

Phase

Phase 1

Healthy volunteers

Yes

Study drug

[C14] selumetinib (oral)

Sex

Male

Actual Enrollment

6

Study type

Interventional

Age

50 Years - 65 Years

Date

Study Start Date: 01 Oct 2013
Primary Completion Date: 01 Nov 2013
Study Completion Date: 01 Nov 2013

Study design

Allocation: N/A
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Feb 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria