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NCT01807000 · ClinicalTrials.gov registry record · Phase 1
Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01807000 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 6 participants.
The verdict
NCT01807000, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- DRUG Radiolabeled Prucalopride Succinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-03-18 |
| Est. Completion | 2013-04-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01807000
The ClinicalTrials.gov registry entry for NCT01807000 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Radiolabeled Prucalopride Succinate is the first listed.
NCT01807000 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01807000 about?
NCT01807000 is a clinical study titled "Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers". 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 h...
What is the current status of trial NCT01807000?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-03-18. Estimated completion is 2013-04-28.
What interventions are being tested in trial NCT01807000?
The interventions under investigation include: Radiolabeled Prucalopride Succinate (DRUG).
Who is sponsoring clinical trial NCT01807000?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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