Trials / Completed
CompletedNCT01786876
Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers
A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C]SPD557 Following a Single Oral Dose in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Shire · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Radiolabeled SPD557 | A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1 |
Timeline
- Start date
- 2013-03-07
- Primary completion
- 2013-04-12
- Completion
- 2013-04-12
- First posted
- 2013-02-08
- Last updated
- 2021-06-10
- Results posted
- 2014-03-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01786876. Inclusion in this directory is not an endorsement.