Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers

Sponsor
AstraZeneca
Study ID
NCT01931761
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
MALE
Age
50 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose \[14C\] selumetinib in volunteers

Key Dates

First listed
Aug 29, 2013
Start date
Oct 31, 2013
Status verified
Jun 2015
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: [C14] selumetinib 75mg single dose
    \[C14\] selumetinib 75mg single dose

Primary Outcome Measure

Concentration of total radioactivity in blood and plasma and percentage of radioactive dose in urine and faeces and total balance [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days ]

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