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

Kowa

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemia

Treatments: Drug: K-312 400 mg QD; Other: Placebo; Drug: K-312 100 mg QD; Drug: K-312 50 mg QD; Drug: K-312 200 mg QD; Drug: K-312 25 mg QD; Drug: K-312 10 mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT02676596

K-312-1.02US

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 6 patient groups

Cohort 1

Other group

Description:

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

Treatment:

Drug: K-312 50 mg QD

Other: Placebo

Cohort 2

Other group

Description:

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

Treatment:

Drug: K-312 100 mg QD

Other: Placebo

Cohort 3

Other group

Description:

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

Treatment:

Other: Placebo

Drug: K-312 200 mg QD

Cohort 4

Other group

Description:

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

Treatment:

Other: Placebo

Drug: K-312 400 mg QD

Cohort 5

Other group

Description:

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

Treatment:

Other: Placebo

Drug: K-312 25 mg QD

Cohort 6

Other group

Description:

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

Treatment:

Other: Placebo

Drug: K-312 10 mg QD