CompletedInterventionalPhase 1Updated Dec 16, 2025
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312 | NCT02676830 | Trialant
CompletedInterventionalPhase 1Updated Feb 18, 2016
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
ClinicalTrials.gov ID
NCT02676830
Lead Sponsor
Kowa Research Institute, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
13Actual
Last Update Posted
Feb 18, 2016Estimated
Start Date
Aug 2014
Primary Completion Date
Feb 2015Actual
Completion Date
Apr 2015Actual
Brief Summary
The purpose of this study is to Evaluation of absorption, metabolism, and excretion of [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects
Dyslipidemia
K-312 100 mg
K-312 100 ug C14 IV
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
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 between the ages of 25 and 45 years, inclusive.
Subject has a body mass index (BMI) of 18.5 to 30 kg/m2, inclusive.
Exclusion Criteria:
Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312.
Clinically relevant abnormalities in clinical laboratory parameters, as judged by the Investigator.