Hyperlipidemia
Conditions
Brief summary
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.
Interventions
DRUGK-312 10 mg QD
DRUGK-312 25 mg QD
DRUGK-312 50 mg QD
DRUGK-312 100 mg QD
DRUGK-312 200 mg QD
DRUGK-312 400 mg QD
OTHERPlacebo
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CETP activity | Days 1, 3, 6, 11, 16, 21, 27 and 30 |
| Area under the plasma concentration | Days 1 and 21 |
Countries
United States
Outcome results
None listed