Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
Phase 1
Completed
- Conditions
- Dyslipidemia
- Interventions
- Drug: K-312 100 mgDrug: K-312 100 ug C14 IV
- Registration Number
- NCT02676830
- Lead Sponsor
- Kowa Research Institute, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 13
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description K-312 K-312 100 mg - K-312 K-312 100 ug C14 IV -
- Primary Outcome Measures
Name Time Method Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing 336 hours post-dose Area under the plasma-concentration time curve to last measured time point 336 hours post-dose
- Secondary Outcome Measures
Name Time Method