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NCT03948581 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
A Phase 1 study of Healthy Volunteers, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT03948581: Completed Phase 1 study of Healthy Volunteers, sponsored by Takeda.
NCT03948581 is a Phase 1 study of Healthy Volunteers that has completed, run by Takeda. The registered enrollment target is 102 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03948581, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
Conditions Studied
Interventions
- DRUG Vedolizumab SC
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2018-09-21 |
| Phase | Phase 1 |
What the finished NCT03948581 record still lists
NCT03948581 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Vedolizumab SC is the first listed.
NCT03948581 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03948581 about?
NCT03948581 is a clinical study titled "A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants". The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
What is the current status of trial NCT03948581?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2018-02-21. Estimated completion is 2018-09-21.
What conditions does trial NCT03948581 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03948581?
The interventions under investigation include: Vedolizumab SC (DRUG).
Who is sponsoring clinical trial NCT03948581?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03948581 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03948581's enrollment target sits among peer trials
102 77th of 283 higher than 207 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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