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NCT00655083 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
A Phase 1 study, sponsored by Menarini Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00655083: Completed Phase 1 study, sponsored by Menarini Group.
NCT00655083 is a Phase 1 study that has completed, run by Menarini Group. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00655083, a Phase 1 study, has completed, sponsored by Menarini Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.
Primary Outcome
Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-\<12 and 12-\<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.
Interventions
- DRUG Nepadutant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-05 |
| Phase | Phase 1 |
What the finished NCT00655083 record still lists
NCT00655083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Nepadutant is the first listed.
NCT00655083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00655083 about?
NCT00655083 is a clinical study titled "A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants". The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.
What is the current status of trial NCT00655083?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2008-03. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00655083?
The interventions under investigation include: Nepadutant (DRUG).
Who is sponsoring clinical trial NCT00655083?
This trial is sponsored by Menarini Group, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00655083's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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