Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
NCT ID: NCT02676596
Last Updated: 2016-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
120 participants
INTERVENTIONAL
2014-04-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Cohort 1
Japanese and Non-Japanese subjects receiving K-312 50 mg QD
K-312 50 mg QD
Placebo
Cohort 2
Japanese and Non-Japanese subjects receiving K-312 100 mg QD
K-312 100 mg QD
Placebo
Cohort 3
Japanese and Non-Japanese subjects receiving K-312 200 mg QD
K-312 200 mg QD
Placebo
Cohort 4
Japanese and Non-Japanese subjects receiving K-312 400 mg QD
K-312 400 mg QD
Placebo
Cohort 5
Japanese and Non-Japanese subjects receiving K-312 25 mg QD
K-312 25 mg QD
Placebo
Cohort 6
Japanese and Non-Japanese subjects receiving K-312 10 mg QD
K-312 10 mg QD
Placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Locations
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Glendale, California, United States
Countries
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Other Identifiers
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K-312-1.02US
Identifier Type: -
Identifier Source: org_study_id
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