NCT01807000

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Shire · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Radiolabeled Prucalopride Succinate	A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.

Timeline

• Start date: 2013-03-18
• Primary completion: 2013-04-28
• Completion: 2013-04-28
• First posted: 2013-03-08
• Last updated: 2021-06-10
• Results posted: 2014-09-05

Locations

1 site across 1 country: United States