Comparing how a tablet and an IV infusion of Vepdegestrant are absorbed in healthy adults

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

This study is testing how well a medication called Vepdegestrant is absorbed in healthy adults when taken as a tablet compared to an IV infusion.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pfizer (Industry-sponsored)
• Locations: 2 sites (Groningen and 1 other locations)
• Trial ID: NCT06911788 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the absorption of Vepdegestrant, a medication, when administered orally versus intravenously in healthy adults. Participants will receive one dose of the medication via IV and another dose orally after a high-fat meal. The study will measure the levels of Vepdegestrant in the bloodstream during both administration methods to determine the bioavailability of the oral formulation. The study lasts for 22 days and includes a stay at the clinical research unit for 9 days during each of the two periods.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females of non-childbearing potential aged 18 years or older with a BMI between 16 and 32 kg/m².

Not a fit: Patients with significant medical history or conditions affecting drug absorption may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective way to administer Vepdegestrant, potentially improving treatment options for future patients.

How similar studies have performed: Previous studies comparing oral and IV drug administration have shown varying success, but this specific approach with Vepdegestrant is novel.

Eligibility criteria

Key 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).

Key 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.

Where this trial is running

Groningen and 1 other locations

• Icon — Groningen, Netherlands (Recruiting)
• ICON - screening centre — Utrecht, Netherlands (Recruiting)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions Healthy Participants