Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:25 - 45
Updated:4/21/2016
Start Date:August 2014
End Date:April 2015

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The purpose of this study is to Evaluation of absorption, metabolism, and excretion of
[14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects


Inclusion Criteria:

- Subject provides written informed consent before any study-specific evaluation is
performed.

- Subject is a healthy adult male between the ages of 25 and 45 years, inclusive.

- Subject has a body mass index (BMI) of 18.5 to 30 kg/m2, inclusive.

Exclusion Criteria:

- Presence of active or recurring clinically significant cardiovascular, pulmonary,
renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic,
gastrointestinal, or metabolic disease requiring medical treatment.

- Any surgical or medical condition that might significantly alter the absorption,
distribution, metabolism, or excretion of K-312.

- Clinically relevant abnormalities in clinical laboratory parameters, as judged by the
Investigator.
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