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

Completed · Phase 1

Conditions studied: Dyslipidemia

In brief

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

Key facts

Study ID

NCT02676830

Run by

Kowa Research Institute, Inc.

People needed

13

Starts

2014-08-01

Expected to finish

2015-04-01

Last updated by the study team

2016-02-18

Who can join

Age: 25 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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