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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.

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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

FieldValue
Enrollment Target 6 participants
Start Date 2013-03-07
Est. Completion 2013-04-12
Phase Phase 1

Sponsor

Shire

245 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.