Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects

Study Overview
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Brief Summary
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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.

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Drug: K-312 10 mg QD
* Drug: K-312 25 mg QD
* Drug: K-312 50 mg QD
* Drug: K-312 100 mg QD
* Drug: K-312 200 mg QD
* Drug: K-312 400 mg QD
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort 1<br>Japanese and Non-Japanese subjects receiving K-312 50 mg QD | Drug: K-312 50 mg QD<br> <br> Other: Placebo<br> <br> |
| Other: Cohort 2<br>Japanese and Non-Japanese subjects receiving K-312 100 mg QD | Drug: K-312 100 mg QD<br> <br> Other: Placebo<br> <br> |
| Other: Cohort 3<br>Japanese and Non-Japanese subjects receiving K-312 200 mg QD | Drug: K-312 200 mg QD<br> <br> Other: Placebo<br> <br> |
| Other: Cohort 4<br>Japanese and Non-Japanese subjects receiving K-312 400 mg QD | Drug: K-312 400 mg QD<br> <br> Other: Placebo<br> <br> |
| Other: Cohort 5<br>Japanese and Non-Japanese subjects receiving K-312 25 mg QD | Drug: K-312 25 mg QD<br> <br> Other: Placebo<br> <br> |
| Other: Cohort 6<br>Japanese and Non-Japanese subjects receiving K-312 10 mg QD | Drug: K-312 10 mg QD<br> <br> Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CETP activity |  | Days 1, 3, 6, 11, 16, 21, 27 and 30 | 
| Area under the plasma concentration |  | Days 1 and 21 |