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OpenTrials
Completed

NCT Number: NCT02676596

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

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.

Completed

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Glendale, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Placebo

Other

Primary outcomes

  1. CETP activity

    Time frame: Days 1, 3, 6, 11, 16, 21, 27 and 30

  2. Area under the plasma concentration

    Time frame: Days 1 and 21

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Feb 8, 2016
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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