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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: Completed Phase 1 study, sponsored by Shire.
NCT01807000 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT01807000 record still lists
NCT01807000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Radiolabeled Prucalopride Succinate is the first listed.
NCT01807000 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01807000's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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