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

A Phase 1, Open-label, Fixed Sequence Study to Evaluate The Effect of Steady-State Dosing of PF-08049820 on the Single Dose Pharmacokinetics of Oral Contraceptives, Midazolam, and Dabigatran in Healthy Adult Female Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	PF-08049820	Administered orally
DRUG	Midazolam	Administered orally
DRUG	Dabigatran Etexilate	Administered orally
DRUG	Portia (EE and LN) or equivalent oral tablet	Administered orally

Timeline

• Start date: 2025-10-03
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2025-09-24
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study