Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers
NCT ID: NCT01931761
Last Updated: 2015-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2013-10-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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[C14] selumetinib 75mg single dose
\[C14\] selumetinib 75mg single dose
[C14] selumetinib (oral)
Single oral administration \[C14\] 75mg
Interventions
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[C14] selumetinib (oral)
Single oral administration \[C14\] 75mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive.
* Regular bowel movements (ie, on average production of at least 1 stool per day).
Exclusion Criteria
* Exposure to radiation levels above background exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
* History or presence of any clinically significant disease or disorder in the opinion of the investigator
* Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results, vital signs or ECG at baseline in the opinion of the Investigator.
50 Years
65 Years
MALE
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Stuart Mair, MD
Role: PRINCIPAL_INVESTIGATOR
University of Aberdeen
Locations
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Research Site
Ruddington, , United Kingdom
Countries
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References
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Dymond AW, Howes C, Pattison C, So K, Mariani G, Savage M, Mair S, Ford G, Martin P. Metabolism, Excretion, and Pharmacokinetics of Selumetinib, an MEK1/2 inhibitor, in Healthy Adult Male Subjects. Clin Ther. 2016 Nov;38(11):2447-2458. doi: 10.1016/j.clinthera.2016.09.002. Epub 2016 Oct 15.
Related Links
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CSR\_Synopsis\_D1532C00077.pdf
Other Identifiers
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D1532C00077
Identifier Type: -
Identifier Source: org_study_id