Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Arvinas Estrogen Receptor, Inc.
Conditions:
Healthy Participants
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 participa...
Eligibility Criteria
Inclusion
- Key
- 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.
- Body mass index (BMI) of 16-32 kg/m2; and a total body weight \>45 kg (99 lb).
- Key
Exclusion
- 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.
- 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.
- 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.
- 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).
- A positive urine drug test
- Screening blood pressure ≥140/90 mm Hg for participants \<60 years; and ≥150/90 mm Hg for participants ≥60 years old.
- Renal impairment as defined by an eGFR in adults \<60 mL/min/1.73 m² based on CKD-EPI equation.
- 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).
- History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- 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.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06911788
Start Date
April 3 2025
End Date
June 13 2025
Last Update
June 29 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
ICON
Groningen, Netherlands, 9728 NZ
2
ICON - screening centre
Utrecht, Netherlands, 3584 BL