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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03948581
The ClinicalTrials.gov registry entry for NCT03948581 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (79% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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