Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers

Shire

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Radiolabeled Prucalopride Succinate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01807000

SPD555-104

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.