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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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