CompletedInterventionalPhase 1Updated Jan 22, 2019
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects | NCT02676596 | Trialant
CompletedInterventionalPhase 1Updated Feb 12, 2016
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
ClinicalTrials.gov ID
NCT02676596
Lead Sponsor
Kowa Research Institute, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
120Actual
Last Update Posted
Feb 12, 2016Estimated
Start Date
Apr 2014
Primary Completion Date
Nov 2014Actual
Completion Date
Jan 2015Actual
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.
Hyperlipidemia
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
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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.