drugset / Trial / NCT07190430

A Study to Learn If the Study Medicine Called PF-08049820 Changes How the Body Processes the Other Study Medicines Called Oral Contraceptives, Midazolam, and Dabigatran in Healthy Adult Female Participants

NCT07190430

Phase 1 Active not recruiting 16 enrolled Pfizer
Non-randomizedSequentialOpen-labelBasic science

Summary

The purpose of this study is to see how a medicine called PF-08049820 affects how other medicines move through the body. This information will help plan future studies. The other medicines include: * Birth control pills (containing ethinyl estradiol and levonorgestrel) * Midazolam (used to help people relax or sleep) * Dabigatran etexilate (used to prevent blood clots) This study is seeking participants who: * are female and are 18 years or older * weigh more than 110 pounds (50 kg) * have a healthy body weight (not too low or too high) * are generally healthy with no serious medical problems. People with serious health problems, recent medicine use, or who had certain vaccines recently cannot join. * are willing to follow all the study rules The study has 6 parts, and each part happens one after the other. In the first 3 parts, participants take just one dose of each medicine (midazolam, dabigatran, and birth control pills) to see how these medicines work alone. In the last 3 parts, they take PF-08049820 twice a day, along with one of the other medicines, to see how PF-08049820 changes the way those medicines move through the body. The whole study will take about 12 to13 weeks and participants will stay overnight in the clinic for about 25 days.

Timeline

Start
2025-10-03
Primary completion
2025-12-15
Completion
2025-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 150 mg Oral
Subject Levonorgestrel Small molecule 150 ug Oral
Subject Midazolam Small molecule 2 mg Oral
Subject PF-08049820 Unknown Oral
Subject ethinyl estradiol Small molecule 30 ug Oral

Indications