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Healthy ParticipantsPhase 1PKNCT06005688

A Study to Understand the Effects of Carbamazepine on How Vepdegestrant is Processed in Healthy Participants

A Phase 1 study testing Vepdegestrant and Carbamazepine in people with Healthy Participants, run by Pfizer at 1 site in Belgium.

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 understand if carbamazepine reacts with vepdegestrant and affects how it is processed in the bodies of healthy participants. This study is seeking participants who: are male, or female who cannot have children. are 18 years or older. are extremely healthy as decided by medical tests. 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 and Carbamazepine
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
18 Aug 2023to 21 Nov 2023
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 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, and cardiac monitoring.
  • BMI of 16-32 kg/m2; and a total body weight >45 kg (99.2 lb).
  • Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the ICD and in this protocol.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.

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 HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, or HCVAb. Hepatitis B vaccination is allowed.
  • Participants shown to carry or be positive for HLA-B*1502 and/or HLA-A*3101 (genotyping alleles/markers related with carbamazepine-associated SJS or TEN).
  • 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.
  • Use of prescription or non-prescription medications, including vitamins, herbal and dietary supplements, grapefruit/grapefruit containing products, and Seville orange/Seville orange containing products within 7 days prior to the first dose of study intervention with the exception of:
Show all 19Show fewer
  • Moderate/strong CYP3A4 inducers which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
  • Moderate/strong CYP3A4 inhibitors which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
  • 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 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.
  • Baseline standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  • 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:
  • AST, ALT, or Total Bilirubin Level >1.05× ULN;
  • Renal impairment as defined by an eGFR <60 mL/min/1.73m². Based upon participant age at screening, eGFR is calculated usding the recommended CKD-EPI equations to determine eligibility and to provide a baseline to quantify any subsequent kidney safety events.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
  • History of 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 vepdegestrant and Tegretol or any of the formulation components of vepdegestrant and Tegretol.
  • Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Pfizer Clinical Research Unit - Brussels

    Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

Official title: An Interventional, Phase 1, Open-Label, Fixed Sequence, 2-Period Study to Estimate the Effect of Multiple Doses of Carbamazepine on the Pharmacokinetics of Single Dose Vepdegestrant (ARV-471, PF-07850327) 200 mg Under the Fed Condition in Healthy Adult Males and Females of Nonchildbearing Potential

The purpose of this study is to understand if carbamazepine reacts with vepdegestrant and affects how it is processed in the bodies of healthy participants.

This study is seeking participants who:

Read more
  • are male, or female who cannot have children.
  • are 18 years or older.
  • are extremely 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).
  • can understand the study needs and provide a signed document to take part in the study.

All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, all participants will receive carbamazepine by mouth once a day for 19 days. Participants will also receive one dose of vepdegestrant by mouth.

The levels of vepdegestrant in Period 1 will be compared to the levels of vepdegestrant in Period 2 to decide if carbamazepine affects how vepdegestrant is processed differently in healthy adults.

The study duration is 27 days and includes two periods. Participants will stay in the clinical research unit through the end of period 2. The participants may be allowed to leave on Day 4 or at the end of Period 1 but must return at the study doctor's call to complete the study. 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, Carbamazepine

What participants receive

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

  • VepdegestrantDrug

    Also called ARV-471, PF-07850327

    Participants will receive a single dose of Vepdegestrant by mouth in Period 1 and Period 2, with a washout period of at least 20 days between two doses of Vepdegestrant.

  • CarbamazepineDrug

    Also called Tegretol

    Participants will receive Carbamazepine by mouth once a day for 19 days in Period 2.

Study groups in NCT06005688
Study groupRoleWhat they receive
Vepdegestrant with and without CarbamazepineExperimentalVepdegestrant administered as a single dose in Period 1 and Period 2. Carbamazepine administered once a day for 19 days in Period 2.
Receives: Drug: Vepdegestrant; Drug: Carbamazepine

What is being measured

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

  1. Maximum Observed Plasma Concentration (Cmax) of Vepdegestrant when administered alone

    Measured: Period 1 - Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hour post-dose

  2. Cmax of Vepdegestrant when administered with carbamazepine

    Measured: Period 2 - Day 14 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hour post-dose

  3. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Vepdegestrant when administered alone

    Measured: Period 1 - Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hour post-dose

  4. AUCinf of Vepdegestrant when administered with carbamazepine

    Measured: Period 2 - Day 14 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hour post-dose

Secondary outcomes (5)

  1. 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.

  2. Number of Participants With Clinical Laboratory Abnormalities

    Measured: Baseline up to Period 2 Day 20

  3. Number of Participants With Electrocardiogram (ECG) Abnormalities

    Measured: Baseline up to Period 2 Day 20

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

    Measured: Baseline up to Period 2 Day 20

  5. Number of Participants With Abnormalities in Physical Examinations

    Measured: Baseline up to Period 2 Day 20

Timeline

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

  1. First posted22 Aug 2023
  2. Study start18 Aug 2023
  3. Primary completion11 Oct 2023
  4. Study completion21 Nov 2023

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
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06005688
Sponsor's protocol ID
C4891011
Other IDs
2023-505881-27, 2023
Acronym
PK
Status last verified
Jan 2024
First submitted
15 Aug 2023
Last updated
16 Jan 2024
Results posted
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.

Publications

  • Wang H, Winton JA, Matschke KT, Stouffs A, Lee KC, Zhang Y, Qiao W, Tan W. Effect of carbamazepine on the pharmacokinetics of vepdegestrant, a PROteolysis TArgeting Chimera estrogen receptor degrader, in healthy adults. Br J Clin Pharmacol. 2026 Jul;92(7):2183-2192. doi: 10.1002/bcp.70482. Epub 2026 Feb 17.

    PubMed 41703907

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vepdegestrant and Carbamazepine in people with Healthy Participants, 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 4 inclusion and 19 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 16 Jan 2024. 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 when administered alone (time frame: Period 1 - Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hour post-dose). The study lists 4 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 NCT06005688, which also lists 1 linked publication.

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 16 Jan 2024.

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