Leeds, United Kingdom
NCT Number: NCT02434835
Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects
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.
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Notify MeKey information
Conditions
Age range
35 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
[14C]KWA-0711
DrugPrimary outcomes
-
Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites
Time frame: 240 hours
-
Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites
Time frame: 240 hours
-
Cumulative radioactivity recovery in urine and feces
Time frame: 240 hours
-
Profiles of metabolites in plasma, urine and faeces
Time frame: 240 hours
Secondary outcomes
-
Number of adverse events
Time frame: 240 hours
Sponsors and collaborators
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Industry
Registry information
Important dates
- Primary completion
- 2015
- First posted
- May 5, 2015
- Registry last updated
- Apr 18, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.