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

NCT02676596 | Completed Phase 1 DMC

• 1 other identifier: K-312-1.02US
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• CETP activity

  Days 1, 3, 6, 11, 16, 21, 27 and 30

• Area under the plasma concentration

  Days 1 and 21

Study Arms (6)

Cohort 1

OTHER

Japanese and Non-Japanese subjects receiving K-312 50 mg QD

Drug: K-312 50 mg QD; Other: Placebo

Cohort 2

OTHER

Japanese and Non-Japanese subjects receiving K-312 100 mg QD

Drug: K-312 100 mg QD; Other: Placebo

Cohort 3

OTHER

Japanese and Non-Japanese subjects receiving K-312 200 mg QD

Drug: K-312 200 mg QD; Other: Placebo

Cohort 4

OTHER

Japanese and Non-Japanese subjects receiving K-312 400 mg QD

Drug: K-312 400 mg QD; Other: Placebo

Cohort 5

OTHER

Japanese and Non-Japanese subjects receiving K-312 25 mg QD

Drug: K-312 25 mg QD; Other: Placebo

Cohort 6

OTHER

Japanese and Non-Japanese subjects receiving K-312 10 mg QD

Drug: K-312 10 mg QD; Other: Placebo

Interventions

K-312 10 mg QD DRUG

Cohort 6

K-312 25 mg QD DRUG

Cohort 5

K-312 50 mg QD DRUG

Cohort 1

K-312 100 mg QD DRUG

Cohort 2

K-312 200 mg QD DRUG

Cohort 3

K-312 400 mg QD DRUG

Cohort 4

Placebo OTHER

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (1)

Unknown Facility

Glendale, California, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 8, 2016
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

US (1)