Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 3/30/2013 |
| Start Date: | April 2013 |
| End Date: | May 2013 |
| Contact: | Shire Call Center |
| Phone: | +1 866 842 5335 |
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Prucalopride Succinate Following a Single Oral Dose in Healthy Male Subjects
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 healthy male volunteers aged 18 to 50 years (inclusive).The
purpose of this study is to investigate how and how quickly Prucalopride Succinate or its
break down products are excreted by analysing blood, faeces and urine samples collected
during the study.
Inclusion Criteria:
- 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 Criteria:
- 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.
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