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

Phase 1

Completed

• Conditions: Hyperlipidemia
• Interventions: 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; Drug: K-312 10 mg QD; Other: Placebo

• Registration Number: NCT02676596
• Lead Sponsor: Kowa Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-11
• Study Completion: 2015-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Placebo	Japanese and Non-Japanese subjects receiving K-312 50 mg QD
Cohort 3	Placebo	Japanese and Non-Japanese subjects receiving K-312 200 mg QD
Cohort 5	K-312 25 mg QD	Japanese and Non-Japanese subjects receiving K-312 25 mg QD
Cohort 1	K-312 50 mg QD	Japanese and Non-Japanese subjects receiving K-312 50 mg QD
Cohort 2	K-312 100 mg QD	Japanese and Non-Japanese subjects receiving K-312 100 mg QD
Cohort 2	Placebo	Japanese and Non-Japanese subjects receiving K-312 100 mg QD
Cohort 3	K-312 200 mg QD	Japanese and Non-Japanese subjects receiving K-312 200 mg QD
Cohort 4	K-312 400 mg QD	Japanese and Non-Japanese subjects receiving K-312 400 mg QD
Cohort 5	Placebo	Japanese and Non-Japanese subjects receiving K-312 25 mg QD
Cohort 6	K-312 10 mg QD	Japanese and Non-Japanese subjects receiving K-312 10 mg QD
Cohort 6	Placebo	Japanese and Non-Japanese subjects receiving K-312 10 mg QD
Cohort 4	Placebo	Japanese and Non-Japanese subjects receiving K-312 400 mg QD

Primary Outcome Measures

Name	Time	Method
CETP activity	Days 1, 3, 6, 11, 16, 21, 27 and 30
Area under the plasma concentration	Days 1 and 21