Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
Conditions
Interventions
PF-08049820
Administered orally
Midazolam
Administered orally
Dabigatran Etexilate
Administered orally
Portia (EE and LN) or equivalent oral tablet
Administered orally
Locations (1)
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States