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

Dyslipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676830
• Other study ID #: K-312-1.03US
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2016
• Last updated: February 16, 2016
• Start date: August 2014
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 45 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• K-312 100 mg
Single oral dose
• K-312 100 ug C14 IV
microtracer dose containing =37 kBq (1000 nCi) [14C] given as a 5-ml IV push over 2 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma-concentration time curve to last measured time point		336 hours post-dose	No
Primary	Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing		336 hours post-dose	No