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: * female who cannot have children. * are 18 years or older. * are overtly 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). 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
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.
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium
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
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