NCT05706753

A Study of Milvexian in Healthy Adult Females

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Janssen Pharmaceutica N.V., Belgium · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-01-25
• Primary completion: 2023-07-20
• Completion: 2023-07-20
• First posted: 2023-01-31
• Last updated: 2025-03-30

Locations

1 site across 1 country: Belgium