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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 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01786876
The ClinicalTrials.gov registry entry for NCT01786876 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 SPD557 is the first listed.
NCT01786876 reports 0 study locations.
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.
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