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Completed

NCT Number: NCT05706753

A Study of Milvexian in Healthy Adult Females

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

SGS Belgium NV

Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy on the basis of physical examination, medical history, and vital signs, and 12-lead electrocardiography (ECG) performed at screening and on 1 day prior midazolam intervention (Day -1)
  • Healthy on the basis of clinical laboratory tests performed at screening and on Day -1 (screening) of the treatment phase. If the results of the serum chemistry panel, coagulation (activated partial thromboplastin time [aPTT] and prothrombin time [PT]), hematology, or urinalysis
  • Body weight not less than 50.0 kilograms (kg) and body mass index (BMI; weight (kg) per height metered square (kg/m^2) within the range 18.5-30.0 kg/m^2 (inclusive) at screening and Day -1
  • All women must have a negative highly sensitive serum human chorionic gonadotropin (beta-hCG) test at screening and urine pregnancy test on Day -1
  • A woman must be: a. Not of childbearing potential or b. Of childbearing potential and practicing a highly effective method of contraception and agrees to remain on a highly effective method (failure rate of less than [<]1 percentage [%] per year when used consistently and correctly) until 4 days (5 half-lives) after last dose of milvexian-the end of relevant exposure

Exclusion criteria

  • History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study intervention to the participant or that could prevent, limit or confound the protocol specified assessments
  • History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study intervention or any of the excipients of milvexian, midazolam, or Drospifem 20 (ethinylestradiol + drospirenone)
  • Clinically significant abnormal values for hematology, coagulation, clinical chemistry or urinalysis at screening or on Day -1 as determined by the investigator or appropriate designee. If any of the following laboratory rules are met at screening or Day -1, the participant should be excluded. A retest is allowed once: hemoglobin or hematocrit < lower limit of normal, platelet count < lower limit of normal, aPTT or PT greater than (>) 1.2 x upper limit of normal (ULN)
  • Received an investigational intervention or used an invasive investigational medical device within 60 days or received a biological product within 3 months, or within a period less than 6 times the drug's half-life, if known, whichever is longer, before the first dose of study intervention or is currently enrolled in an investigational study
  • Has used hormonal contraception injections or implants within 6 months of the first study intervention administration or has used any other hormonal contraception within 30 days of the first study intervention administration on Day 1

Treatment and study plan

Milvexian

Drug

Milvexian will be administered orally.

Other names: JNJ-70033093, BMS-986177

midazolam

Drug

Midazolam will be administered orally.

Ethinylestradiol

Drug

Ethinylestradiol will be administered orally.

Drospirenone

Drug

Drospirenone will be administered orally.

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidzolam

    Time frame: Up to Day 19

    Cmax is defined as the maximum observed plasma concentration of midazolam and 1-hydroxymidzolam.

  2. 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

    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.

  3. Area Under the Plasma Concentration-time Curve from Time 0 to Infinite time (AUC[0-infinity]) 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.

  4. Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol and Drospirenone

    Time frame: Up to Day 25

    Cmax is defined as the maximum observed plasma concentration of ethinylestradiol and drospirenone.

  5. 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

    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.

  6. Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) 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.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Milvexian

    Time frame: Up to Day 19

    Cmax is defined as the maximum observed plasma concentration of milvexian.

  2. Maximum Observed Plasma Concentration of Milvexian at Steady-state (Cmax,ss)

    Time frame: Up to Day 19

    Cmax,ss is defined as the maximum observed plasma concentration of milvexian at steady-state.

  3. Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Observed Quantifiable Concentration (AUC[0-last]) of Milvexian

    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.

  4. 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

    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).

  5. Number of Participants with Adverse Events (AEs)

    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.

  6. Number of Participants with Adverse Events (AEs) of Interest

    Time frame: Up to 16 weeks

    AEs of Interest includes bleeding events, liver enzyme elevation and clinical liver events, and cutaneous events.

  7. Number of Participants with Abnormalities in Vital Signs

    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.

  8. Number of Participants with Abnormalities in Electrocardiograms (ECGs)

    Time frame: Up to 16 weeks

    Number of participants with abnormalities in ECGs will be reported.

  9. Number of Participants with Abnormalities in Clinical Laboratory Tests

    Time frame: Up to 16 weeks

    Number of participants with abnormalities in clinical laboratory tests will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutica N.V., Belgium

Industry

Collaborators

  • Bristol Myers Squibb Company (BMS)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2023
Registry last updated
Mar 30, 2025

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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