Healthy Male Subject
Conditions
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.
Interventions
DRUG[14C]KWA-0711
Sponsors
Kissei Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
MALE
Age
35 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites | 240 hours |
| Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites | 240 hours |
| Cumulative radioactivity recovery in urine and feces | 240 hours |
| Profiles of metabolites in plasma, urine and faeces | 240 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events | 240 hours |
Countries
United Kingdom
Outcome results
None listed