A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293

Completed · Phase 1

Conditions studied: Healthy Volunteers, Mass Balance Study

In brief

This study will be an open-label, non-randomized, absorption, metabolism, and excretion study to evaluate the mass balance, metabolite profiles, and rates and routes of elimination of \[14C\]-AZD3293 and derived metabolites following administration as a single 100-mg (containing approximately 150 µCi) oral dose (as an oral solution)

Key facts

Study ID

NCT02126514

Run by

AstraZeneca

People needed

12

Starts

2014-05-01

Expected to finish

2014-05-01

Last updated by the study team

2014-06-16

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may not qualify if…

• Participation in any prior study of AZD3293 or previous enrollment in the present study; 2) Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, interfere with absorption, distribution, metabolism or excretion of drugs, or influence the results or the subject's ability to participate in the study; 3) History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;

Where it is running

• Research Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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