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ACTIVE NOT RECRUITING
NCT07190430
PHASE1

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-10-03

Completion Date

2025-12-15

Last Updated

2025-12-09

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, United States