Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-04-30

Brief Summary

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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

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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K-312

Group Type EXPERIMENTAL

K-312 100 mg

Intervention Type DRUG

Single oral dose

K-312 100 ug C14 IV

Intervention Type DRUG

microtracer dose containing ≤37 kBq (1000 nCi) \[14C\] given as a 5-ml IV push over 2 minutes

Interventions

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K-312 100 mg

Single oral dose

Intervention Type DRUG

K-312 100 ug C14 IV

microtracer dose containing ≤37 kBq (1000 nCi) \[14C\] given as a 5-ml IV push over 2 minutes

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes