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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Other: Placebo; 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: K-312 25 mg QD; Drug: K-312 10 mg QD

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort 1; Japanese and Non-Japanese subjects receiving K-312 50 mg QD	Other: Placebo; Drug: K-312 50 mg QD
Other: Cohort 2; Japanese and Non-Japanese subjects receiving K-312 100 mg QD	Other: Placebo; Drug: K-312 100 mg QD
Other: Cohort 3; Japanese and Non-Japanese subjects receiving K-312 200 mg QD	Other: Placebo; Drug: K-312 200 mg QD
Other: Cohort 4; Japanese and Non-Japanese subjects receiving K-312 400 mg QD	Other: Placebo; Drug: K-312 400 mg QD
Other: Cohort 5; Japanese and Non-Japanese subjects receiving K-312 25 mg QD	Other: Placebo; Drug: K-312 25 mg QD
Other: Cohort 6; Japanese and Non-Japanese subjects receiving K-312 10 mg QD	Other: Placebo; Drug: K-312 10 mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CETP activity	Days 1, 3, 6, 11, 16, 21, 27 and 30
Area under the plasma concentration	Days 1 and 21

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Estimate): February 12, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: K-312-1.02US