Dyslipidemia
Conditions
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
Interventions
DRUGK-312 100 mg
Single oral dose
DRUGK-312 100 ug C14 IV
microtracer dose containing ≤37 kBq (1000 nCi) \[14C\] given as a 5-ml IV push over 2 minutes
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma-concentration time curve to last measured time point | 336 hours post-dose |
| Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing | 336 hours post-dose |
Countries
United States
Outcome results
None listed