A Phase 1 interventional study of Midazolam and Vepdegestrant in Healthy Participants, sponsored by Pfizer. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-21.
Sponsored by Pfizer · Phase 1, Interventional, and Other
The purpose of this study is to learn if the study medicine called Vepdegestrant changes how the body processes the other study medicine called Midazolam.
This study is seeking participants who:
All participants in this study will receive one dose of midazolam alone by mouth in Period 1. In Period 2, all participants will receive vepdegestrant by mouth once a day for 15 days. Participants will also receive one dose of midazolam by mouth on day 1 and day 15.
The levels of midazolam in Period 1 will be compared to the levels of midazolam in Period 2 Day 1 and Day 15 to decide if vepdegestrant affects how midazolam is processed differently in healthy adults.
The study duration is 22 days and includes two periods. Participants will stay in the clinical research unit through the end of period 2. A follow-up visit for each participant takes place at 28 to 35 days after taking the study medicine for the last time.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
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. Refer to Section 6.9 Prior and Concomitant Therapy for additional details.
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:
Midazolam administered as a single dose in Period 1 Day 1, and Period 2 Day 1 and Day 15. Vepdegestrant administered once a day for 15 days in Period 2.
Drug: Midazolam · Drug: Vepdegestrant
Participants will receive a single dose of Midazolam by mouth in Period 1 Day 1, and Period 2 Day 1 and Day 15
Participants will receive Vepdegestrant by mouth once a day for 15 days in Period 2.
Also known as: ARV-471, PF-07850327
Maximum Observed Plasma Concentration (Cmax) of Midazolam when administered alone
Time frame: Period 1 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
Cmax of Midazolam following multiple doses of Vepdegestrant
Time frame: Period 2 - Day 15 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hour post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Midazolam when administered alone
Time frame: Period 1 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
AUCinf of Midazolam following multiple doses of Vepdegestrant
Time frame: Period 2 - Day 15 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hour post-dose
Cmax of Midazolam following a single dose of Vepdegestrant
Time frame: Period 2 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
AUCinf of Midazolam following a single dose of Vepdegestrant
Time frame: Period 2 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Time the participant provides informed consent through and including follow-up contact occurring 28 to 35 calendar days after the last administration of the study intervention.
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Baseline up to Period 2 Day 20
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to Period 2 Day 20
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: Baseline up to Period 2 Day 20
Number of Participants With Abnormalities in Physical Examinations
Time frame: Baseline up to Period 2 Day 20
Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast) of Midazolam when administered alone
Time frame: Period 1 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
AUClast of Midazolam following multiple doses of Vepdegestrant
Time frame: Period 2 - Day 15 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hour post-dose
AUClast of Midazolam following a slinge dose of Vepdegestrant
Time frame: Period 2 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
Time for Cmax (Tmax) of Midazolam when administered alone
Time frame: Period 1 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
Tmax of Midazolam following multiple doses of Vepdegestrant
Time frame: Period 2 - Day 15 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hour post-dose
Tmax of Midazolam following a slinge dose of Vepdegestrant
Time frame: Period 2 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
Apparent clearance (CL/F) of Midazolam when administered alone
Time frame: Period 1 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
CL/F of Midazolam following multiple doses of Vepdegestrant
Time frame: Period 2 - Day 15 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hour post-dose
CL/F of Midazolam following a slinge dose of Vepdegestrant
Time frame: Period 2 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
Apparent volume of distribution (Vz/F) of Midazolam when administered alone
Time frame: Period 1 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
Vz/F of Midazolam following multiple doses of Vepdegestrant
Time frame: Period 2 - Day 15 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hour post-dose
Vz/F of Midazolam following a slinge dose of Vepdegestrant
Time frame: Period 2 - Day 1 pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hour post-dose
Plan to share: 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.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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