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

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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