Skip to main content
OpenTrials
Completed

NCT Number: NCT02676830

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Madison, Wisconsin, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

K-312 100 mg

Drug

Single oral dose

K-312 100 ug C14 IV

Drug

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

Primary outcomes

  1. Area under the plasma-concentration time curve to last measured time point

    Time frame: 336 hours post-dose

  2. Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing

    Time frame: 336 hours post-dose

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 8, 2016
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.