Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03961308 · 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 Autoinjector (PFS+AI) in Healthy Participants

A Phase 1 study of Healthy Volunteers, sponsored by Takeda.

Completed
Registry status
Phase 1
Development phase
204
Enrollment target
2
Study locations

NCT03961308 is a Phase 1 study of Healthy Volunteers that has completed, run by Takeda. The registered enrollment target is 204 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (58% lower). The trial reports 2 study locations across 2 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03961308, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 1
Development phase
204 participants
Enrollment target
2
Study locations

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

Healthy Volunteers

Interventions

  • DRUG Vedolizumab SC

Study Locations (2)

Arizona

  • Celerion - Tempe

Nebraska

  • Celerion - Lincoln

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2018-03-12
Est. Completion 2018-11-21
Phase Phase 1

Sponsor

Takeda

408 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03961308

The ClinicalTrials.gov registry entry for NCT03961308 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 204 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 (58% 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.

NCT03961308 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Nebraska.

Frequently Asked Questions

What is clinical trial NCT03961308 about?

NCT03961308 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 Autoinjector (PFS+AI) 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 NCT03961308?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 204 participants. The study started on 2018-03-12. Estimated completion is 2018-11-21.

What conditions does trial NCT03961308 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT03961308?

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

Who is sponsoring clinical trial NCT03961308?

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

Where is trial NCT03961308 being conducted?

This trial has 2 study locations across Arizona, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Healthy Volunteers

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Healthy Volunteers

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.