CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 6 enrolled
Drug / intervention
Radiolabeled Prucalopride Succinatedrug
Likely dose
Radiolabeled Prucalopride Succinate 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01807000
NCT01807000Phase 1Completed
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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

Shire·interventional·Posted Mar 8, 2013·Updated Jun 10, 2021

In Brief

A Phase 1 clinical trial evaluating Radiolabeled Prucalopride Succinate for Healthy. Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2013
Enrollment StartMar 18, 2013
Primary CompletionApr 28, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.3 years ago

Interventions

Radiolabeled Prucalopride Succinatedrug

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