Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931
NCT ID: NCT01284595
Last Updated: 2014-08-13
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
2011-03-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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AZD8931
\[14C\] AZD8931
[14C] AZD8931
Single 160 mg oral dose administered on Day 1
Interventions
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[14C] AZD8931
Single 160 mg oral dose administered on Day 1
Eligibility Criteria
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Inclusion Criteria
* Regular daily bowel movements (ie, production of at least 1 stool per day).
* Non-smokers or ex-smokers who have stopped smoking for \>3 months before Visit 1 and have not used nicotine products for \>3 months
* Healthy Male volunteers aged 50 to 65 years, inclusive
Exclusion Criteria
* Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1).
* History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)
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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Darren Wilbraham, MBBS, DCPSA
Role: PRINCIPAL_INVESTIGATOR
Quintiles Drug Research Unit at Guy's Hospital
Mary Stuart
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
London, , United Kingdom
Countries
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References
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Ballard P, Swaisland HC, Malone MD, Sarda S, Ghiorghiu S, Wilbraham D. Metabolic disposition of AZD8931, an oral equipotent inhibitor of EGFR, HER2 and HER3 signalling, in rat, dog and man. Xenobiotica. 2014 Dec;44(12):1083-98. doi: 10.3109/00498254.2014.938257. Epub 2014 Jul 9.
Related Links
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Other Identifiers
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D0102C00007
Identifier Type: -
Identifier Source: org_study_id
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