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

Shire6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Radiolabeled Prucalopride SuccinateDRUG

A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Covance Global Clinical Research Unit Inc.

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled Prucalopride Succinate

AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.