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HealthyPhase 1NCT06275841

A Study to Learn If the Study Medicine Esomeprazole Changes How the Body Processes the Other Study Medicine Vepdegestrant

A Phase 1 study testing vepdegestrant and esomeprazole in people with Healthy, run by Pfizer at 1 site in United States.

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 the study is to investigate the effect of multiple doses of a proton-pump inhibitor (PPI) esomeprazole on the PK of vepdegestrant under fed conditions in healthy adult participants. All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. 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?
vepdegestrant and esomeprazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
23 Feb 2024to 24 May 2024
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, vital signs and standard 12-lead ECGs.
  • 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 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.
  • Breastfeeding female participants; Male participants with partners currently pregnant; fertile male participants who have partners of childbearing potential and are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 30 days after the last dose of investigational product.
  • Participants with known history of sensitivity to vepdegestrant or esomeprazole or any of the formulation components of vepdegestrant or esomeprazole.
  • Use of prescription or nonprescription drugs and/or dietary and/or herbal supplements and/or vitamins within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. (Refer to Section 6.9 Prior and Concomitant Therapy for additional details). A longer washout is required for those that fall into the categories below:
  • Acid-reducing agents such as PPI (except as study drug administered) must be discontinued at least 14 days prior to the first dose of study intervention.
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  • Moderate or strong CYP3A inducers which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
  • Moderate or strong CYP3A inhibitor which are prohibited within 14 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 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.
  • Renal impairment as defined by an eGFR <60 mL/min/1.73 m2. Based upon participant age at Screening, eGFR is calculated using the recommended formulas in Section 10.7.2 to determine eligibility and to provide a baseline to quantify any subsequent kidney safety events.
  • For eligibility assessment based upon estimated renal function, the higher of the Screening and baseline eGFR values may be used.
  • Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete 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:
  • ALT, AST, or Total Bilirubin Level ≥1.5 × ULN.
  • 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.
  • 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.

United States1 site

  • Pfizer Clinical Research Unit - New Haven

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF ESOMEPRAZOLE ON THE PHARMACOKINETICS OF SINGLE DOSE VEPDEGESTRANT (ARV-471, PF-07850327) UNDER THE FED CONDITION IN HEALTHY ADULT MALES AND HEALTHY ADULT FEMALES OF NONCHILDBEARING POTENTIAL

The purpose of the study is to investigate the effect of multiple doses of a proton-pump inhibitor (PPI) esomeprazole on the PK of vepdegestrant under fed conditions in healthy adult participants.

All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, everyone will receive esomeprazole by mouth once a day for multiple 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 determine if the PPI affects how vepdegestrant is processed differently in healthy adults.

Conditions
Healthy
Being tested
vepdegestrant, esomeprazole

What participants receive

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

  • vepdegestrantDrug

    experimental

  • esomeprazoleDrug

    Experimental treatment to assess an endpoint

Study groups in NCT06275841
Study groupRoleWhat they receive
vepdegestrant with or without esomeprazoleExperimentalvepdegestrant administered as a single dose in Period 1 and Period 2. Esomeprazole administered once a day for 5 days in Period 2
Receives: Drug: vepdegestrant; Drug: esomeprazole

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 vepdegestrant is administered alone

    Measured: Period 1 - Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose

  2. Maxium observed plasma concentration of vepdegestrant when vepdegestrant is administered with esomeprazole

    Measured: Period 2 - Day 5 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose

  3. Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered alone

    AUCinf=area under the plasama concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0-t) plus AUC (t-inf)

    Measured: Period 1 - Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose

  4. Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered with esomeprazole

    AUCinf=area under the plasama concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0-t) plus AUC (t-inf)

    Measured: Period 2 - Day 5 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose

Secondary outcomes (4)

  1. number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs)

    An AE is any untoward medical occurence in a participant who received study drug without regard to possibility of causal relationship with the study treatmnet. SAE is defined as one of hte following: is fatal or life-threatening; results in persistent or significant disability/incapacity; constitues a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset data occurring during the on-treatment period. AEs include all SAEs and non-SAEs.

    Measured: time the participant provides informed censent through and including follow-up contact occurring 28-35 calendar days after the last administration of the study intervention

  2. Number of participants with clinical laboratory abnormalities

    Following parameters were analyezed for laboratory examination: hematology (Hemoglobin, Hematocrit, RBC count, Platelet count, WBC count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); liver function (AST, ALT, Total bilirubin, Alkaline phosphatase, Albumin, Total protein); renal function (blood Urea nitrogen, Creatinine, Cystatin Ca, uric acid); eletrolytes (Calcium, Sodium, Potassium Chloride, Total CO2 (bicarbonate)); clinical chemistry (glucose); urinalysis (dipstick [decimal logarithm of reciprocal of hydrogen ion activity [pH] of urine, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, bilirubin], microscopy

    If Hb/RBC abnormal:

    MCV, MCH, MCHC

    )

    Measured: baseline up to Period 2 Day 12

  3. Number of participants with electrocardiogram (ECG) abnormalities

    ECG abnormalities criteria include 2) a postdose QTcF is increased by >60 ms from the baseline and is >450 ms; or b) an absolute QTcF value is >500 ms for any scheduled ECG.

    Measured: Baseline up to Period 2 Day 12

  4. Number of participans with clinically significant change from baseline in vital signs

    Blood pressure and pulse rate will be performed following at least a 5-minute rest in a supine position

    Measured: Baseline up to Period 2 Day 12

Timeline

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

  1. First posted23 Feb 2024
  2. Study start23 Feb 2024
  3. Primary completion3 May 2024
  4. Study completion24 May 2024

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275841
Sponsor's protocol ID
C4891035
Status last verified
May 2024
First submitted
16 Feb 2024
Last updated
3 Jun 2024
Results posted
No
FDA-regulated drug
Yes
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 and esomeprazole in people with Healthy, run by Pfizer at 1 site in United States.

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 3 Jun 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 United States. 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 vepdegestrant is administered alone (time frame: Period 1 - Day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours 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 NCT06275841.

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 3 Jun 2024.

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Clinical Trial NCT06275841 | AzTrials