SGS Belgium NV
Edegem, 2650, Belgium
NCT Number: NCT05706753
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.
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Notify Me18 year–55 year
Female
Interventional
Phase 1
Edegem, 2650, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Milvexian will be administered orally.
Other names: JNJ-70033093, BMS-986177
Midazolam will be administered orally.
Ethinylestradiol will be administered orally.
Drospirenone will be administered orally.
Time frame: Up to Day 19
Cmax is defined as the maximum observed plasma concentration of midazolam and 1-hydroxymidzolam.
Time frame: Up to Day 19
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
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 25
Cmax is defined as the maximum observed plasma concentration of ethinylestradiol and drospirenone.
Time frame: Up to Day 25
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
AUC(0-infinity) is defined as the area under the plasma concentration-time curve of from time 0 to infinite time ethinylestradiol and drospirenone.
Time frame: Up to Day 19
Cmax is defined as the maximum observed plasma concentration of milvexian.
Time frame: Up to Day 19
Cmax,ss is defined as the maximum observed plasma concentration of milvexian at steady-state.
Time frame: Up to Day 19
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
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 16 weeks
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
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 (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 ECGs will be reported.
Time frame: Up to 16 weeks
Number of participants with abnormalities in clinical laboratory tests will be reported.
Janssen Pharmaceutica N.V., Belgium
Industry
An Open-label, Non-randomized Study to Investigate the Effects of Twice-Daily Milvexian Administration on the Pharmacokinetics of Single Doses of Midazolam, Ethinylestradiol and Drospirenone in Healthy Adult Females
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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