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

Last updated: May 6, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Vepdegestrant (Reference)

Vepdegestrant (Test)

Clinical Study ID

NCT06911788
C4891037
2024-518134-92-00
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

  • 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Male participants, and/or female participants of non-childbearing potential who arehealthy as determined by medical evaluation including medical history, physicalexamination, laboratory tests, and cardiac monitoring.

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

Exclusion

Key Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, orallergic disease.
  • Any condition possibly affecting drug absorption (eg, gastrectomy,cholecystectomy)

  • History of or positive testing for HIV infection, hepatitis B, or hepatitis C.

  1. Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality or other conditions thatmay increase the risk of study participation or, in the investigator's judgment,make the participant inappropriate for the study.

  2. Use of prescription or nonprescription drugs and dietary and herbal supplements,grapefruit/grapefruit containing products, and Seville orange/Seville orangecontaining products within 7 days or 5 half lives (whichever is longer) prior to thefirst dose of study intervention.

  3. Previous administration with an investigational product (drug or vaccine) within 30days or 5 half lives preceding the first dose of study intervention used in thisstudy (whichever is longer).

  4. A positive urine drug test

  5. Screening blood pressure ≥140/90 mm Hg for participants <60 years; and ≥150/90 mm Hgfor participants ≥60 years old.

  6. Renal impairment as defined by an eGFR in adults <60 mL/min/1.73 m² based on CKD-EPIequation.

  7. Standard 12 lead electrocardiogram that demonstrates clinically relevantabnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete left bundle branch block, signs of a myocardialinfarction, ST T interval changes suggestive of myocardial ischemia, second or thirddegree AV block, or serious bradyarrhythmias or tachyarrhythmias).

  8. History of alcohol abuse or repeated binge drinking and/or any other illicit druguse or dependence within 6 months of Screening.

  9. 6 months prior or current use of tobacco or nicotine-containing products in excessof the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.

  10. History of sensitivity to heparin or heparin-induced thrombocytopenia.

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Vepdegestrant (Reference)
Phase: 1
Study Start date:
April 03, 2025
Estimated Completion Date:
June 17, 2025

Connect with a study center

  • ICON

    Groningen, 9728 NZ
    Netherlands

    Active - Recruiting

  • ICON - screening centre

    Utrecht, 3584 BL
    Netherlands

    Active - Recruiting

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