Status:
COMPLETED
Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers
Lead Sponsor:
Shire
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\] Prucalopride Succinate in h...
Eligibility Criteria
Inclusion
- Males aged between 18 and 50 years, inclusive
- Body mass index (BMI) of ≥18 and ≤30 kg/m2
- No more than 2 bowel movements per day or fewer than 3 bowel movement per week
- Provision of signed and dated, written informed consent prior to any study specific procedures
Exclusion
- Have participated in a \[14C\]-study within the last 6 months.
- Exposure to clinically significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring).
- Male subjects who consume more than 21 units of alcohol per week or 3 units per day.
Key Trial Info
Start Date :
March 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01807000
Start Date
March 18 2013
End Date
April 28 2013
Last Update
June 10 2021
Active Locations (1)
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1
Covance Global Clinical Research Unit Inc.
Madison, Wisconsin, United States, 53704