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Hormone Therapy

single dose of vepdegestrant (3-period, 3-treatment, 6-sequence, crossover) 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168 hours post dose

Awards & highlights

Study Summary

This trial is looking at how a medicine called vepdegestrant is processed in the bodies of healthy adult participants after they eat. They are looking for healthy male and female participants who cannot have children

Who is the study for?

Healthy adults who can participate: men and women unable to have children, aged 18 or older, weighing over 45 kg (99 lbs), with a BMI of 16-32. They must be able to consent to the study and follow its procedures.Check my eligibility

What is being tested?

The trial is testing how different tablet forms of Vepdegestrant are absorbed in the body after eating. Participants will randomly receive three treatments in varying sequences across three periods, with breaks in between for the drug to clear from their system.See study design

What are the potential side effects?

Since this is a study involving healthy individuals and not much detail on side effects is provided, it's expected that any potential side effects would be closely monitored and reported by the research team.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168 hours post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168 hours post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, and 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, 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 [AUC (0 - ∞)] for vepdegestrant

Maximum observed concentration (Cmax) for vepdegestrant

Secondary outcome measures

Number of Participants With Clinical Laboratory Abnormalities

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Number of Participants With Electrocardiogram (ECG) Abnormalities

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: single dose of vepdegestrant (3-period, 3-treatment, 6-sequence, crossover)Experimental Treatment3 Interventions

Vepdegestrant administered as a single dose in Period 1, 2 and 3.

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,571 Previous Clinical Trials

10,916,489 Total Patients Enrolled

Arvinas Estrogen Receptor, Inc.Industry Sponsor

17 Previous Clinical Trials

2,321 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,477 Previous Clinical Trials

8,092,707 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA granted approval for a one-time administration of vepdegestrant in the specified study design with three periods, three treatments, six sequences, and using a crossover approach?

"Given the design of this Phase 1 trial involving a single dose of vepdegestrant, our team at Power rates its safety as a 1 on a scale from 1 to 3. This rating reflects the limited data available supporting both safety and efficacy at this early stage of research."

Answered by AI

Is the enrollment process open for this medical study at present?

"Indeed, the details on clinicaltrials.gov show that this research study is actively seeking participants. Initially listed on April 2nd, 2024, it was last modified on April 12th of the same year. The trial aims to recruit a total of 48 individuals from a single site."

Answered by AI

What is the total number of individuals currently under research in this clinical trial?

"Indeed, according to clinicaltrials.gov, this investigation is actively seeking volunteers. The trial was first listed on 4/2/2024 and last revised on 4/12/2024. Researchers aim to enroll 48 participants from a single research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults

2024. "A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06347861.

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