Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
NCT02676830 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2016-02-18
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
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Kowa Research Institute, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 25 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2015-02-28
- Completion
- 2015-04-30
Countries
- United States
Study Locations
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