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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 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 64 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04465396
The ClinicalTrials.gov registry entry for NCT04465396 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Teduglutide is the first listed.
NCT04465396 reports 0 study locations.
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.
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