A Study of Milvexian in Healthy Adult Females

NCT ID: NCT05706753

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2023-07-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Milvexian + Midazolam + Ethinylestradiol/Drospirenone

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.

Group Type: EXPERIMENTAL

Milvexian

Intervention Type: DRUG

Milvexian will be administered orally.

Midazolam

Intervention Type: DRUG

Midazolam will be administered orally.

Ethinylestradiol

Intervention Type: DRUG

Ethinylestradiol will be administered orally.

Drospirenone

Intervention Type: DRUG

Drospirenone will be administered orally.

Interventions

Milvexian

Milvexian will be administered orally.

Intervention Type: DRUG

Midazolam

Midazolam will be administered orally.

Intervention Type: DRUG

Ethinylestradiol

Ethinylestradiol will be administered orally.

Intervention Type: DRUG

Drospirenone

Drospirenone will be administered orally.

Intervention Type: DRUG

Other Intervention Names

JNJ-70033093; BMS-986177

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol Myers Squibb Company (BMS)

UNKNOWN

Sponsor Role: collaborator

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V., Belgium ClinicalTrial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V., Belgium

Locations

SGS Belgium NV

Edegem, , Belgium

Countries

Belgium

Other Identifiers

2022-002828-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

70033093THR1009

Identifier Type: OTHER

Identifier Source: secondary_id

CR109284

Identifier Type: -

Identifier Source: org_study_id