Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
Status and phase
Completed
Phase 1
Conditions
Dyslipidemia
Treatments
Drug: K-312 100 ug C14 IV
Drug: K-312 100 mg
Details and patient eligibility
About
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
Enrollment
13 patients
Sex
Male
Ages
25 to 45 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Basic Science
Allocation
N/A
Interventional model
Single Group Assignment
Masking
None (Open label)
13 participants in 1 patient group
K-312
Experimental group
Treatment:
Drug: K-312 100 mg
Drug: K-312 100 ug C14 IV
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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