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AzTrials

Healthy ParticipantsPhase 1NCT06911788

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

A Phase 1 study testing Vepdegestrant (Reference) and Vepdegestrant (Test) in people with Healthy Participants, run by Pfizer at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Vepdegestrant (Reference) and Vepdegestrant (Test)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesNetherlands
Study dates
3 Apr 2025to 13 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Body mass index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (99 lb).

Who cannot join

  • 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.
  • 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.
  • 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.
  • 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).
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  • A positive urine drug test
  • Screening blood pressure ≥140/90 mm Hg for participants <60 years; and ≥150/90 mm Hg for participants ≥60 years old.
  • Renal impairment as defined by an eGFR in adults <60 mL/min/1.73 m² based on CKD-EPI equation.
  • 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).
  • History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  • 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.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • ICON

    Groningen, 9728 NZ

  • ICON - screening centre

    Utrecht, 3584 BL

Other trials in Netherlands

About this study

Official title: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD, SINGLE-DOSE, CROSS-OVER STUDY TO ESTIMATE THE ABSOLUTE BIOAVAILABILITY OF VEPDEGESTRANT (ARV-471, PF-07850327) FOLLOWING ORAL AND INTRAVENOUS DOSING OF THE DRUG TO HEALTHY PARTICIPANTS

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:

Read more
  • 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.

Being tested
Vepdegestrant (Reference), Vepdegestrant (Test)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vepdegestrant (Reference)Drug

    Also called ARV-471, PF-07850327

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

  • Vepdegestrant (Test)Drug

    Also called ARV-471, PF-07850327

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

Study groups in NCT06911788
Study groupRoleWhat they receive
Vepdegestrant oral and IV administrationExperimentalParticipants 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.
Receives: Drug: Vepdegestrant (Reference); Drug: Vepdegestrant (Test)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-normalized (dn) Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Vepdegestrant after oral administration

    dn AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) divided by dose. It is obtained from AUC (0 - t) plus AUC (t - ∞).

    Measured: At predefined intervals throughout the treatment period, up to approximately 1 week after the last dose of Vepdegestrant

  2. Dose-normalized (dn) Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Vepdegestrant after IV administration

    dn AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

    Measured: At predefined intervals throughout the treatment period, up to approximately 1 week after the last dose of Vepdegestrant

Secondary outcomes (4)

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: First dose of Vepdegestrant through 35 days after last dose Vepdegestrant

  2. Number of Participants With Clinical Laboratory Abnormalities

    Measured: First dose of Vepdegestrant through 35 days after last dose Vepdegestrant

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

    Measured: First dose of Vepdegestrant through 35 days after last dose Vepdegestrant

  4. Number of Participants With Electrocardiogram (ECG) Abnormalities

    Measured: First dose of Vepdegestrant through 35 days after last dose Vepdegestrant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start3 Apr 2025
  3. Primary completion23 May 2025
  4. Study completion13 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06911788
Sponsor's protocol ID
C4891037
Other IDs
2024-518134-92-00
Status last verified
Jun 2025
First submitted
28 Mar 2025
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vepdegestrant (Reference) and Vepdegestrant (Test) in people with Healthy Participants, run by Pfizer at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-normalized (dn) Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Vepdegestrant after oral administration (time frame: At predefined intervals throughout the treatment period, up to approximately 1 week after the last dose of Vepdegestrant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06911788.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.

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