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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002828-12 | EudraCT Number | ||
| 70033093THR1009 | Other Identifier | Janssen Pharmaceutica N.V., Belgium |
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| Name | Class |
|---|---|
| Bristol Myers Squibb Company (BMS) | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milvexian + Midazolam + Ethinylestradiol/Drospirenone | Experimental | Participants will receive midazolam on Day 1 and Day 19; ethinylestradiol and drospirenone on Day 2 and Day 20; and milvexian from Day 7 to Day 24. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milvexian | Drug | Milvexian will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidzolam | Cmax is defined as the maximum observed plasma concentration of midazolam and 1-hydroxymidzolam. | 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. | 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. | 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. | 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. | Up to Day 25 |
| Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Ethinylestradiol and Drospirenone |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Milvexian | Cmax is defined as the maximum observed plasma concentration of milvexian. | Up to Day 19 |
| Maximum Observed Plasma Concentration of Milvexian at Steady-state (Cmax,ss) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica N.V., Belgium ClinicalTrial | Janssen Pharmaceutica N.V., Belgium | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Belgium NV | Edegem | 2650 | Belgium |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| C000720754 | milvexian |
| D008874 | Midazolam |
| D004997 | Ethinyl Estradiol |
| C035144 | drospirenone |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | Midazolam will be administered orally. |
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| Ethinylestradiol | Drug | Ethinylestradiol will be administered orally. |
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| Drospirenone | Drug | Drospirenone will be administered orally. |
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AUC(0-infinity) is defined as the area under the plasma concentration-time curve of from time 0 to infinite time ethinylestradiol and drospirenone.
| Up to Day 25 |
Cmax,ss is defined as the maximum observed plasma concentration of milvexian at steady-state.
| 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. | 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). | 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. | 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. | 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. | Up to 16 weeks |
| Number of Participants with Abnormalities in Electrocardiograms (ECGs) | Number of participants with abnormalities in ECGs will be reported. | 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. | Up to 16 weeks |
| D006571 | Heterocyclic Compounds |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |