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NCT03949621 · ClinicalTrials.gov registry record · Phase 1

A 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, sponsored by Takeda.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT03949621 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 24 participants.

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The verdict

NCT03949621, a Phase 1 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

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.

Interventions

  • DRUG Vedolizumab SC

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2018-02-06
Est. Completion 2018-08-13
Phase Phase 1

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT03949621

The ClinicalTrials.gov registry entry for NCT03949621 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Vedolizumab SC is the first listed.

NCT03949621 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03949621 about?

NCT03949621 is a clinical study titled "A 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 NCT03949621?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-02-06. Estimated completion is 2018-08-13.

What interventions are being tested in trial NCT03949621?

The interventions under investigation include: Vedolizumab SC (DRUG).

Who is sponsoring clinical trial NCT03949621?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.