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NCT01732263 · ClinicalTrials.gov registry record · Phase 1
Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT01732263: Completed Phase 1 study, sponsored by Shire.
NCT01732263 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01732263, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared with subjects with healthy normal liver function.
Primary Outcome
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 SSP-004184
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-11-09 |
| Est. Completion | 2013-04-01 |
| Phase | Phase 1 |
What the finished NCT01732263 record still lists
NCT01732263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 1 intervention - of which SSP-004184 is the first listed.
NCT01732263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01732263 about?
NCT01732263 is a clinical study titled "Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function". The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared with subjects with healthy normal ...
What is the current status of trial NCT01732263?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2012-11-09. Estimated completion is 2013-04-01.
What interventions are being tested in trial NCT01732263?
The interventions under investigation include: SSP-004184 (DRUG).
Who is sponsoring clinical trial NCT01732263?
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 NCT01732263's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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