A Study to Learn How a Tablet Compared With an IV Infusion of the Study Medicine Called Vepdegestrant is Taken up Into the Blood in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-03

Study Completion Date

2025-06-13

Brief Summary

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The purpose of this study is to learn how much of the study medicine called Vepdegestrant will reach the bloodstream when given orally compared to given intravenously.

This study is seeking participants who:

* are healthy males and healthy females who cannot have children.
* are 18 years or older.
* are healthy as decided by medical tests.
* have a body mass index (BMI) of 16 to 32 kilogram per meter squared.
* have a total body weight of more than 45 kilograms (99 pounds).

In Period 1, all participants will receive one dose of Vepdegestrant by IV. In Period 2, all participants will receive one dose of Vepdegestrant by mouth following a high-fat breakfast. The levels of Vepdegestrant in Period 1 will be compared to the levels of Vepdegestrant in Period 2 and the bioavailablility of the oral formulation of Vepdegestrant will be determined.

The study duration is 22 days and includes two periods. Participants will stay in the clinical research unit for 9 days (8 nights) during each period. A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Vepdegestrant oral and IV administration

Participants will receive a single IV infusion of Vepdegestrant on Day 1 of Period 1 followed by a single 200 mg dose of Vepdegestrant registrational tablet on Day 1 of Period 2.

Group Type EXPERIMENTAL

Vepdegestrant (Reference)

Intervention Type DRUG

Participants will receive a single intravenous (IV) dose of Vepdegestrant on Period 1 Day 1

Vepdegestrant (Test)

Intervention Type DRUG

Participants will receive a 200 mg single oral dose of Vepdegestrant tablet formulation on Period 2 Day 1

Interventions

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Vepdegestrant (Reference)

Participants will receive a single intravenous (IV) dose of Vepdegestrant on Period 1 Day 1

Intervention Type DRUG

Vepdegestrant (Test)

Participants will receive a 200 mg single oral dose of Vepdegestrant tablet formulation on Period 2 Day 1

Intervention Type DRUG

Other Intervention Names

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ARV-471, PF-07850327 ARV-471, PF-07850327

Eligibility Criteria

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Inclusion Criteria

1. Male participants, and/or female participants of non-childbearing potential who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
2. Body mass index (BMI) of 16-32 kg/m2; and a total body weight \>45 kg (99 lb).

Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.

* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy)
* History of or positive testing for HIV infection, hepatitis B, or hepatitis C.
2. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
3. Use of prescription or nonprescription drugs and dietary and herbal supplements, grapefruit/grapefruit containing products, and Seville orange/Seville orange containing products within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
4. Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
5. A positive urine drug test
6. Screening blood pressure ≥140/90 mm Hg for participants \<60 years; and ≥150/90 mm Hg for participants ≥60 years old.
7. Renal impairment as defined by an eGFR in adults \<60 mL/min/1.73 m² based on CKD-EPI equation.
8. Standard 12 lead electrocardiogram that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF \>450 ms, complete left bundle branch block, signs of a myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias).
9. History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
10. 6 months prior or current use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.
11. History of sensitivity to heparin or heparin-induced thrombocytopenia.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes