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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Prucalopride Succinate Following a Single Oral Dose in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Radiolabeled Prucalopride Succinate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiolabeled Prucalopride Succinate<br> | Drug: Radiolabeled Prucalopride Succinate<br>* A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Over 240 hours post-dose | 
| Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered. | Over 240 hours post-dose | 
| Time to Maximum Plasma Concentration (Tmax) of Radiolabelled Prucalopride Succinate | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. | Over 240 hours post-dose | 
| Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate | The time it takes for the blood plasma concentration of a substance to halve. | Over 240 hours post-dose | 
| Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate | The rate at which a drug is removed from the body. | Over 240 hours post-dose | 
| Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate | The distribution of a medication between plasma and the rest of the body. | Over 240 hours post-dose | 
| AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate |  | Over 240 hours post-dose | 
| Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate |  | Over 240 hours post-dose | 
| Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate |  | Over 240 hours post-dose | 
| Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate |  | Over 240 hours post-dose | 
| AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate |  | Over 240 hours post-dose | 
| Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate |  | Over 240 hours post-dose | 
| Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate |  | Over 240 hours post-dose | 
| Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate |  | Over 240 hours post-dose | 
| Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate |  | 240 hours post-dose | 
| Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate |  | Over 240 hours post-dose |