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A Study of Milvexian in Healthy Adult Females

NCT05706753 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-30

No results posted yet for this study

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

Interventions

DRUG

Milvexian

Milvexian will be administered orally.

DRUG

Midazolam

Midazolam will be administered orally.

DRUG

Ethinylestradiol

Ethinylestradiol will be administered orally.

DRUG

Drospirenone

Drospirenone will be administered orally.

Sponsors & Collaborators

  • Bristol Myers Squibb Company (BMS)

    collaborator UNKNOWN

  • Janssen Pharmaceutica N.V., Belgium

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica N.V., Belgium ClinicalTrial · Janssen Pharmaceutica N.V., Belgium

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2023-07-20
Completion
2023-07-20

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05706753 on ClinicalTrials.gov