A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 5/5/2014 |
Start Date: | May 2014 |
End Date: | May 2014 |
Contact: | Anastasia Blesener |
Email: | ClinicalTrialTransparency@astrazeneca.com |
Phone: | (608) 395-3757 |
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion After Oral Administration of [14C]-AZD3293 to Healthy Male Subjects
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)
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)
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) following at least an
8-hour fast from food (not including water). Seven healthy male subjects will be enrolled in
the study at a single study site to complete a minimum of 6 subjects. The study will consist
of 2 visits.
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) following at least an
8-hour fast from food (not including water). Seven healthy male subjects will be enrolled in
the study at a single study site to complete a minimum of 6 subjects. The study will consist
of 2 visits.
Inclusion Criteria:
- Healthy male subjects between 18 and 55 years of age, inclusive, at the time of
consent with suitable veins for cannulation or repeated venipuncture;
- Body weight between 50 to 100 kg, inclusive;
- Within BMI range 19 to 30 kg/m2, inclusive;
- In good health, as determined by no clinically significant findings from medical
history, physical examination with neurological examination, 12-lead ECG, and vital
signs as judged by the Investigator;
Exclusion Criteria:
- Participation in any prior study of AZD3293 or previous enrollment in the present
study;
- 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;
- History of significant hypersensitivity, intolerance, or allergy to any drug
compound, food, or other substance, unless approved by the Investigator;
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