Back to resultsEvaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
K-312 100 mg
K-312 100 ug C14 IV
Sponsored by
About this trial
This is an interventional basic science trial for Dyslipidemia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
K-312
Arm Description
Outcomes
Primary Outcome Measures
Area under the plasma-concentration time curve to last measured time point
Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing
Secondary Outcome Measures
Full Information
NCT ID
NCT02676830
First Posted
February 2, 2016
Last Updated
February 16, 2016
Sponsor
Kowa Research Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02676830
Brief Title
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
K-312
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
K-312 100 mg
Intervention Description
Single oral dose
Intervention Type
Drug
Intervention Name(s)
K-312 100 ug C14 IV
Intervention Description
microtracer dose containing ≤37 kBq (1000 nCi) [14C] given as a 5-ml IV push over 2 minutes
Primary Outcome Measure Information:
Title
Area under the plasma-concentration time curve to last measured time point
Time Frame
336 hours post-dose
Title
Oral bioavailability based on the ratio of AUC after oral dosing to the AUC after i.v. dosing
Time Frame
336 hours post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
City
Madison
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
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