HealthyPhase 1NCT06645938
A Study to Learn How Different Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood in Healthy Adults
A Phase 1 study testing single dose of vepdegestrant as tablet formulation (Treatment A) and single dose of vepdegestrant as tablet formulation (Treatment B) in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of the study is to compare the amount vepdegestrant available from two different tablet formulations under fed conditions in healthy adult participants; 200 mg vepdegestrant alternative tablet formulation compared to 200 mg vepdegestrant standard tablet formulation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- single dose of vepdegestrant as tablet formulation (Treatment A) and single dose of vepdegestrant as tablet formulation (Treatment B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Oct 2024to 14 Mar 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 aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead ECGs.
- BMI of 16-32 kg/m2; and a total body weight >45 kg (99.2 lb).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of or active human immunodeficiency virus (HIV) infection, Hepatitis B, or Hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Participants with known history of sensitivity to vepdegestrant or any of the formulation components of vepdegestrant.
- Use of any prescription or nonprescription drugs/products, dietary and herbal supplements, vitamins, grapefruit/grapefruit containing products, and Seville orange/Seville orange containing products are prohibited in this study. A washout of 7 days or 5 halflives (whichever is longer) prior to the first dose of study intervention is required. A longer washout is required for those that fall into the categories below:
Show all 16Show fewer
- Moderate or strong cytochrome P450 (CYP)3A inducers which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
- Moderate or strong CYP3A inhibitors which are prohibited within 14 days or 5 half lives (whichever is longer) prior to the first dose of study intervention (unless otherwise indicated in the protocol).
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
- A positive urine drug test. A single repeat for positive drug screen may be allowed.
- Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
- Renal impairment as defined by an estimated glomerular filtration rate (eGFR) (units of mL/min/1.73 m²) in adults <60 mL/min/1.73 m² based on chronic kidney disease epidemiology (CKD-EPI) equation. Based upon participant age at screening, eGFR, is calculated using the recommended formulas to determine eligibility and to provide a baseline to quantify any subsequent kidney safety events.
- Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTc corrected using Fridericia's formula [QTcF] >450 ms, complete left bundle branch block (LBBB), signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal (ULN);
- Total bilirubin ≥ 1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A PHASE I, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 2-TREATMENT, 2-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY ADULT PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF AN VARIANT (HIGH HARDNESS) TABLET OF VEPDEGESTRANT (ARV-471, PF-07850327) RELATIVE TO THE REGISTRATIONAL TABLET
The purpose of the study is to compare the amount vepdegestrant available from two different tablet formulations under fed conditions in healthy adult participants; 200 mg vepdegestrant alternative tablet formulation compared to 200 mg vepdegestrant standard tablet formulation.
This study is seeking male or female participants of non-childbearing potential age who:
Read more
- 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; and a total body weight of more than 45 kilograms (99 pounds).
All participants will be put into groups to receive one of the 2 treatments in each period. This study will consist of 2 treatment sequences:
- Sequence 1: Single 200 mg dose of vepdegestrant registrational tablet in Period 1, followed by a single 200 mg dose of vepdegestrant variant tablet in Period 2.
- Sequence 2: Single 200 mg dose of vepdegestrant variant tablet in Period 1, followed by a single 200 mg dose of vepdegestrant registrational tablet in Period 2.
Participants will be in the study for about 11 weeks.
- Conditions
- Healthy
- Being tested
- single dose of vepdegestrant as tablet formulation (Treatment A), single dose of vepdegestrant as tablet formulation (Treatment B)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single dose of vepdegestrant as tablet formulation (Treatment A)Drug
Also called ARV-471, PF-07850327
Single 200 mg dose of vepdegestrant registrational (200 mg strength) tablet.
single dose of vepdegestrant as tablet formulation (Treatment B)Drug
Also called ARV-471, PF-07850327
Single 200 mg dose of vepdegestrant variant (200 mg strength) tablet.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Treatment A followed by Treatment B | Experimental | Participants will receive a single 200 mg dose of vepdegestrant registrational tablet on Day 1 of Period 1 followed by a single 200 mg dose of vepdegestrant variant tablet on Day 1 of Period 2. Receives: Drug: single dose of vepdegestrant as tablet formulation (Treatment A); Drug: single dose of vepdegestrant as tablet formulation (Treatment B) |
| Sequence 2: Treatment B followed by Treatment A | Experimental | Participants will receive a single 200 mg dose of vepdegestrant variant tablet 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: single dose of vepdegestrant as tablet formulation (Treatment A); Drug: single dose of vepdegestrant as tablet formulation (Treatment B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Vepdegestrant
Measured: Period 1 and 2 - pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, and 168 hour(s) post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Vepdegestrant
Measured: Period 1 and 2 - pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, and 168 hour(s) post-dose
Secondary outcomes (4)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs).
Measured: Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Number of Participants With Clinical Laboratory Abnormalities.
Measured: Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs.
Measured: Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Number of Participants With Electrocardiogram (ECG) Abnormalities.
Measured: Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start16 Oct 2024
- Primary completion20 Feb 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arvinas Estrogen Receptor, Inc.
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645938
- Sponsor's protocol ID
- C4891038
- Other IDs
- 2024-514169-21-00
- Status last verified
- May 2025
- First submitted
- 23 Sep 2024
- Last updated
- 25 May 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 2-TREATMENT, 2-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY ADULT PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF AN VARIANT (HIGH HARDNESS) TABLET OF VEPDEGESTRANT (ARV-471, PF-07850327) RELATIVE TO THE REGISTRATIONAL TABLET
- ClinicalTrials.gov ID
- NCT06645938
- Acronym / sponsor ID
- C4891038
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Arvinas Estrogen Receptor, Inc.
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the amount vepdegestrant available from two different tablet formulations under fed conditions in healthy adult participants; 200 mg vepdegestrant alternative tablet formulation compared to 200 mg vepdegestrant standard tablet formulation.
This study is seeking male or female participants of non-childbearing potential age who:
- 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; and a total body weight of more than 45 kilograms (99 pounds).
All participants will be put into groups to receive one of the 2 treatments in each period. This study will consist of 2 treatment sequences:
- Sequence 1: Single 200 mg dose of vepdegestrant registrational tablet in Period 1, followed by a single 200 mg dose of vepdegestrant variant tablet in Period 2.
- Sequence 2: Single 200 mg dose of vepdegestrant variant tablet in Period 1, followed by a single 200 mg dose of vepdegestrant registrational tablet in Period 2.
Participants will be in the study for about 11 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Treatment A followed by Treatment B | Experimental | Drug: single dose of vepdegestrant as tablet formulation (Treatment A), Drug: single dose of vepdegestrant as tablet formulation (Treatment B)Participants will receive a single 200 mg dose of vepdegestrant registrational tablet on Day 1 of Period 1 followed by a single 200 mg dose of vepdegestrant variant tablet on Day 1 of Period 2. |
| Sequence 2: Treatment B followed by Treatment A | Experimental | Drug: single dose of vepdegestrant as tablet formulation (Treatment A), Drug: single dose of vepdegestrant as tablet formulation (Treatment B)Participants will receive a single 200 mg dose of vepdegestrant variant tablet on Day 1 of Period 1 followed by a single 200 mg dose of vepdegestrant registrational tablet on Day 1 of Period 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male participants, and/or female participants of non-childbearing potential aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead ECGs.
- BMI of 16-32 kg/m2; and a total body weight >45 kg (99.2 lb).
Key exclusion criteria (16 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Participants with known history of sensitivity to vepdegestrant or any of the formulation components of vepdegestrant.
- Use of any prescription or nonprescription drugs/products, dietary and herbal supplements, vitamins, grapefruit/grapefruit containing products, and Seville orange/Seville orange containing products are prohibited in this study. A washout of 7 days or 5 halflives (whichever is longer) prior to the first dose of study intervention is required. A longer washout is required for those that fall into the categories below:
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single dose of vepdegestrant as tablet formulation (Treatment A)Also: ARV-471, PF-07850327Single 200 mg dose of vepdegestrant registrational (200 mg strength) tablet. | Drug | Sequence 1: Treatment A followed by Treatment B, Sequence 2: Treatment B followed by Treatment A |
| single dose of vepdegestrant as tablet formulation (Treatment B)Also: ARV-471, PF-07850327Single 200 mg dose of vepdegestrant variant (200 mg strength) tablet. | Drug | Sequence 1: Treatment A followed by Treatment B, Sequence 2: Treatment B followed by Treatment A |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Vepdegestrant
Time frame: Period 1 and 2 - pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, and 168 hour(s) post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Vepdegestrant
Time frame: Period 1 and 2 - pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, and 168 hour(s) post-dose
4 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time frame: Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Number of Participants With Clinical Laboratory Abnormalities.
Time frame: Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs.
Time frame: Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Number of Participants With Electrocardiogram (ECG) Abnormalities.
Time frame: Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing single dose of vepdegestrant as tablet formulation (Treatment A) and single dose of vepdegestrant as tablet formulation (Treatment B) in people with Healthy, run by Pfizer at 1 site in Belgium.
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 16 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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Maximum Observed Plasma Concentration (Cmax) of Vepdegestrant (time frame: Period 1 and 2 - pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120, 144, and 168 hour(s) post-dose). 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?
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 25 May 2025.