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

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: K-312 100 mg; Drug: K-312 100 ug C14 IV

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: K-312	Drug: K-312 100 mg; Single oral dose; 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

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Estimate): February 18, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: K-312-1.03US