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

Hyperlipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676596
• Other study ID #: K-312-1.02US
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2016
• Last updated: February 11, 2016
• Start date: April 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• 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

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CETP activity		Days 1, 3, 6, 11, 16, 21, 27 and 30	No
Primary	Area under the plasma concentration		Days 1 and 21	No