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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-12-09

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-03
Primary Completion
2025-12-15
Completion
2025-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07190430 on ClinicalTrials.gov