Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects
ClinicalTrials.gov ID
NCT02434835
Lead Sponsor
Kissei Pharmaceutical Co., Ltd.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Last Update Posted
Apr 18, 2016Estimated
Primary Completion Date
May 2015Actual
Brief Summary
The purpose of this study is to evaluate the absorption, metabolism and excretion following a single oral dose of [14C]KWA-0711 to healthy male subjects.
Healthy Male Subject
[14C]KWA-0711
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
No data available
Eligibility Criteria
Inclusion Criteria:
Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive.
Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.
Subjects who have a body weight between 50 and 100 kg, inclusive.
Subjects must have regular bowel movements.
Exclusion Criteria:
Subjects who have an abnormality in heart rate, blood pressure , temperature or 12-lead ECG.
Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the 3 months prior to dose administration.
Subjects who have had a clinically significant illness within 4 weeks of dose administration as determined by the Investigator.
Subjects who have any clinically significant abnormal laboratory safety findings.
Subjects who have had an X ray or who have participated in any clinical trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.