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NCT04465396 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT04465396: Completed Phase 1 study, sponsored by Shire.
NCT04465396 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04465396, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the bioavailability of teduglutide administered as a single subcutaneous (SC) fixed dose (depending upon participant weightband assignment) delivered by a syringe injection and the same fixed dose delivered by the pen injector in healthy participants.
Interventions
- DRUG Teduglutide
- DEVICE Syringe Injection
- DEVICE Pen injector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-01-13 |
| Est. Completion | 2021-08-20 |
| Phase | Phase 1 |
What the finished NCT04465396 record still lists
NCT04465396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Teduglutide is the first listed.
NCT04465396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04465396 about?
NCT04465396 is a clinical study titled "A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants". The purpose of this study is to evaluate the bioavailability of teduglutide administered as a single subcutaneous (SC) fixed dose (depending upon participant weightband assignment) delivered by a syringe injection and the same fixed dose delivered by the pen injector in healthy participants.
What is the current status of trial NCT04465396?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2021-01-13. Estimated completion is 2021-08-20.
What interventions are being tested in trial NCT04465396?
The interventions under investigation include: Teduglutide (DRUG), Syringe Injection (DEVICE), Pen injector (DEVICE).
Who is sponsoring clinical trial NCT04465396?
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 NCT04465396's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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