The purpose of this study is to measure the effect of milvexian given for approximately 2 weeks on (a) how the liver metabolizes other drugs (in this case one called midazolam), and (b) the pharmacokinetics (the way the body absorbs, distributes, and gets rid of a drug) of an oral contraceptive pill in healthy adult females.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Milvexian will be administered orally.
Midazolam will be administered orally.
Ethinylestradiol will be administered orally.
SGS Belgium NV
Edegem, Belgium
Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidzolam
Cmax is defined as the maximum observed plasma concentration of midazolam and 1-hydroxymidzolam.
Time frame: Up to Day 19
Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC[0-last]) of Midazolam and 1-hydroxymidzolam
AUC(0-last) is defined as area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of midazolam and 1-hydroxymidzolam.
Time frame: Up to Day 19
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite time (AUC[0-infinity]) of Midazolam and 1-hydroxymidzolam
AUC(0-infinity) is defined as the area under the plasma concentration-time curve from time 0 to infinite time of midazolam and 1-hydroxymidzolam.
Time frame: Up to Day 19
Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol and Drospirenone
Cmax is defined as the maximum observed plasma concentration of ethinylestradiol and drospirenone.
Time frame: Up to Day 25
Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC[0-last]) of Ethinylestradiol and Drospirenone
AUC(0-last) is defined as area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of ethinylestradiol and drospirenone.
Time frame: Up to Day 25
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Ethinylestradiol and Drospirenone
AUC(0-infinity) is defined as the area under the plasma concentration-time curve of from time 0 to infinite time ethinylestradiol and drospirenone.
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Drospirenone will be administered orally.
Time frame: Up to Day 25
Maximum Observed Plasma Concentration (Cmax) of Milvexian
Cmax is defined as the maximum observed plasma concentration of milvexian.
Time frame: Up to Day 19
Maximum Observed Plasma Concentration of Milvexian at Steady-state (Cmax,ss)
Cmax,ss is defined as the maximum observed plasma concentration of milvexian at steady-state.
Time frame: Up to Day 19
Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC[0-last]) of Milvexian
AUC(0-last) is defined as area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of milvexian.
Time frame: Up to Day 19
Area Under the Plasma Concentration-time Curve of Milvexian over the Dosing Interval (tau) at Steady-state (AUCtau,ss)
AUCtau,ss is defined as the area under the plasma concentration-time curve of milvexian over the dosing interval (tau) at steady-state (AUCtau,ss).
Time frame: Up to Day 19
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Time frame: Up to 16 weeks
Number of Participants with Adverse Events (AEs) of Interest
AEs of Interest includes bleeding events, liver enzyme elevation and clinical liver events, and cutaneous events.
Time frame: Up to 16 weeks
Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs (including blood pressure, pulse/heart rate, respiratory rate, body temperature) will be reported.
Time frame: Up to 16 weeks
Number of Participants with Abnormalities in Electrocardiograms (ECGs)
Number of participants with abnormalities in ECGs will be reported.
Time frame: Up to 16 weeks
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests will be reported.
Time frame: Up to 16 weeks