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

Primary Purpose

Hyperlipidemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

K-312 10 mg QD

K-312 25 mg QD

K-312 50 mg QD

K-312 100 mg QD

K-312 200 mg QD

K-312 400 mg QD

Placebo

About this trial

This is an interventional basic science trial for Hyperlipidemia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Arm Description

Japanese and Non-Japanese subjects receiving K-312 50 mg QD

Japanese and Non-Japanese subjects receiving K-312 100 mg QD

Japanese and Non-Japanese subjects receiving K-312 200 mg QD

Japanese and Non-Japanese subjects receiving K-312 400 mg QD

Japanese and Non-Japanese subjects receiving K-312 25 mg QD

Japanese and Non-Japanese subjects receiving K-312 10 mg QD

Outcomes

Primary Outcome Measures

CETP activity

Area under the plasma concentration

Secondary Outcome Measures

Full Information

NCT ID

NCT02676596

First Posted

February 2, 2016

Last Updated

February 11, 2016

Sponsor

Kowa Research Institute, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02676596

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kowa Research Institute, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Other

Arm Description

Japanese and Non-Japanese subjects receiving K-312 50 mg QD

Arm Title

Cohort 2

Arm Type

Other

Arm Description

Japanese and Non-Japanese subjects receiving K-312 100 mg QD

Arm Title

Cohort 3

Arm Type

Other

Arm Description

Japanese and Non-Japanese subjects receiving K-312 200 mg QD

Arm Title

Cohort 4

Arm Type

Other

Arm Description

Japanese and Non-Japanese subjects receiving K-312 400 mg QD

Arm Title

Cohort 5

Arm Type

Other

Arm Description

Japanese and Non-Japanese subjects receiving K-312 25 mg QD

Arm Title

Cohort 6

Arm Type

Other

Arm Description

Japanese and Non-Japanese subjects receiving K-312 10 mg QD

Intervention Type

Drug

Intervention Name(s)

K-312 10 mg QD

Intervention Type

Drug

Intervention Name(s)

K-312 25 mg QD

Intervention Type

Drug

Intervention Name(s)

K-312 50 mg QD

Intervention Type

Drug

Intervention Name(s)

K-312 100 mg QD

Intervention Type

Drug

Intervention Name(s)

K-312 200 mg QD

Intervention Type

Drug

Intervention Name(s)

K-312 400 mg QD

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

CETP activity

Time Frame

Days 1, 3, 6, 11, 16, 21, 27 and 30

Title

Area under the plasma concentration

Time Frame

Days 1 and 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

City

Glendale

State/Province

California

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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