Vepdegestrant (Reference)
DrugParticipants will receive a single intravenous (IV) dose of Vepdegestrant on Period 1 Day 1
Other names: ARV-471, PF-07850327
NCT Number: NCT06911788
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
ICON, Groningen, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants will receive a single intravenous (IV) dose of Vepdegestrant on Period 1 Day 1
Other names: ARV-471, PF-07850327
Participants will receive a 200 mg single oral dose of Vepdegestrant tablet formulation on Period 2 Day 1
Other names: ARV-471, PF-07850327
Time frame: At predefined intervals throughout the treatment period, up to approximately 1 week after the last dose of Vepdegestrant
dn AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) divided by dose. It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time frame: At predefined intervals throughout the treatment period, up to approximately 1 week after the last dose of Vepdegestrant
dn AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time frame: First dose of Vepdegestrant through 35 days after last dose Vepdegestrant
Time frame: First dose of Vepdegestrant through 35 days after last dose Vepdegestrant
Time frame: First dose of Vepdegestrant through 35 days after last dose Vepdegestrant
Time frame: First dose of Vepdegestrant through 35 days after last dose Vepdegestrant
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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