← Back to Search

Proton Pump Inhibitor

vepdegestrant with or without esomeprazole for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI of 16-32 kg/m2; and a total body weight >45 kg (99.2 lb)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up period 2 - day 5 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose

Awards & highlights

Study Summary

"This trial aims to see how a medication called esomeprazole affects the levels of another medication called vepdegestrant in the body. Healthy adults will take vepdegestrant alone at

Who is the study for?

This trial is for healthy adults. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study's results or their own safety.Check my eligibility

What is being tested?

The study is testing how esomeprazole, a common heartburn medication, affects the body's processing of vepdegestrant when taken together. Participants will first take vepdegestrant alone, then in combination with esomeprazole to compare differences.See study design

What are the potential side effects?

While specific side effects aren't listed for this trial, generally esomeprazole can cause headache, stomach pain, nausea or diarrhea. Vepdegestrant may also have its own side effects which would be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is between 16 and 32, and I weigh more than 99.2 lbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ period 2 - day 5 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~period 2 - day 5 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and period 2 - day 5 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered alone

Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered with esomeprazole

Maximum observed plasma concentration (Cmax) of vepdegestrant when vepdegestrant is administered alone

+1 more

Secondary outcome measures

Number of participans with clinically significant change from baseline in vital signs

Number of participants with clinical laboratory abnormalities

Number of participants with electrocardiogram (ECG) abnormalities

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: vepdegestrant with or without esomeprazoleExperimental Treatment2 Interventions

vepdegestrant administered as a single dose in Period 1 and Period 2. Esomeprazole administered once a day for 5 days in Period 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

esomeprazole

2008

Completed Phase 4

~4241960

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Arvinas Estrogen Receptor, Inc.Industry Sponsor

17 Previous Clinical Trials

2,357 Total Patients Enrolled

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,970 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,188 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being enrolled in this ongoing medical study?

"As documented on clinicaltrials.gov, this investigation is not presently seeking volunteers. The trial was initially published on 2/23/2024 and last revised on 2/16/2024. Despite the current non-enrollment status of this study, there are currently 814 other ongoing trials actively enrolling participants."

Answered by AI

What are the potential risks of vepdegestrant when taken with or without esomeprazole in patients?

"In this Phase 1 trial, the safety assessment of vepdegestrant with or without esomeprazole is scored as a 1 by our team at Power due to the limited evidence available regarding its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn If the Study Medicine Esomeprazole Changes How the Body Processes the Other Study Medicine Vepdegestrant

2024. "A Study to Learn If the Study Medicine Esomeprazole Changes How the Body Processes the Other Study Medicine Vepdegestrant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06275841.

All > Nexium