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NCT01786876 · ClinicalTrials.gov registry record · Phase 1
Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01786876: Completed Phase 1 study, sponsored by Shire.
NCT01786876 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
NCT01786876, 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 \[14C\] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly SPD557 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.
Primary Outcome
Area under the plasma concentration versus time curve from time 0 to infinity. 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 SPD557
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-03-07 |
| Est. Completion | 2013-04-12 |
| Phase | Phase 1 |
What the finished NCT01786876 record still lists
NCT01786876 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 SPD557 is the first listed.
NCT01786876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01786876 about?
NCT01786876 is a clinical study titled "Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers". Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quick...
What is the current status of trial NCT01786876?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-03-07. Estimated completion is 2013-04-12.
What interventions are being tested in trial NCT01786876?
The interventions under investigation include: Radiolabeled SPD557 (DRUG).
Who is sponsoring clinical trial NCT01786876?
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 NCT01786876'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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