A Study of Milvexian in Healthy Adult Females

NCT05706753 | Completed Phase 1

• 3 other identifiers: CR1092842022-002828-1270033093THR1009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Female

Outcome Measures

Primary Outcomes (6)

• 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

  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

Secondary Outcomes (9)

• Maximum Observed Plasma Concentration (Cmax) of Milvexian

  Up to Day 19

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

  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

  Up to Day 19

• 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)

  Up to 16 weeks

Study Arms (1)

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.

Drug: Milvexian; Drug: Midazolam; Drug: Ethinylestradiol; Drug: Drospirenone

Interventions

Milvexian DRUG

Milvexian will be administered orally.

Also known as: JNJ-70033093, BMS-986177

Milvexian + Midazolam + Ethinylestradiol/Drospirenone

Midazolam DRUG

Midazolam will be administered orally.

Milvexian + Midazolam + Ethinylestradiol/Drospirenone

Ethinylestradiol DRUG

Ethinylestradiol will be administered orally.

Milvexian + Midazolam + Ethinylestradiol/Drospirenone

Drospirenone DRUG

Drospirenone will be administered orally.

Milvexian + Midazolam + Ethinylestradiol/Drospirenone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead
• Bristol Myers Squibb Company (BMS): collaborator

Study Sites (1)

SGS Belgium NV

Edegem, 2650, Belgium

Location

MeSH Terms

Interventions

milvexian; Midazolam; Ethinyl Estradiol; drospirenone

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Janssen Pharmaceutica N.V., Belgium ClinicalTrial

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: January 31, 2023
• Study Start: January 25, 2023
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)