Trials / Completed
CompletedNCT01824446
AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]SSP-004184 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 – 65 Years
- Healthy volunteers
- Accepted
Summary
To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the study drug. Further, the study will determine how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it when given as a single dose to healthy male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Radiolabeled SPD602 (FBS0701, SSP-004184) | A single oral dose of 3g of radio-labelled SSP-004184 on Day 1 |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2013-05-29
- Completion
- 2013-05-29
- First posted
- 2013-04-04
- Last updated
- 2021-06-24
- Results posted
- 2014-05-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01824446. Inclusion in this directory is not an endorsement.