Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | January 2015 |
The purpose of this study is to investigate the safety tolerability, and PK profile of K-312
and its metabolites in healthy Japanese and non-Japanese adults.
and its metabolites in healthy Japanese and non-Japanese adults.
Inclusion Criteria:
- Subject provides written informed consent before any study-specific evaluation is
performed.
- Subject is a healthy adult male or a female of non-childbearing potential between the
ages of 18 and 45 years, inclusive.
- Subject has a body mass index of 18.5 to 30 kg/m2, inclusive.
- Subject has hematology, coagulation, serum chemistry, and urinalysis test results
within the reference ranges or showing no clinically relevant deviations, as judged
by the Investigator.
Exclusion Criteria:
- Subject has the presence of an active or recurring clinically significant
cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric,
immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical
treatment.
- Subject has any surgical or medical condition that might significantly alter the
absorption, distribution, metabolism, or excretion of K-312. Cholecystectomy is
permitted if there are no postcholecystectomy gastrointestinal symptoms.
- Subject has clinically relevant abnormalities in clinical laboratory parameters.
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