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

Last updated: December 8, 2025
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

1

Condition

Atopic Dermatitis

Dermatitis, Atopic

Eczema (Atopic Dermatitis)

Treatment

Portia (EE and LN) or equivalent oral tablet

PF-08049820

Midazolam

Clinical Study ID

NCT07190430
C6231004
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female participants ≥18 years of age, at screening who are overtly healthy asdetermined by medical evaluation including medical history, physical examination,laboratory tests, and cardiac monitoring.

  • BMI of 16 to 32 kg/m2; and a total body weight >50 kg (110 lb).

  • Participants who are willing and able to comply with all scheduled visits, treatmentplan, laboratory tests, and other study procedures.

Exclusion

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, orallergic disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at the time of dosing).

  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV,Hepatitis B surface antigen (HBsAg), Antibody to hepatitis B surface antigen (HBsAb), Hepatitis B core antibody (HBcAb), or Hepatitis C Virus Antibody (HCVAb). Apositive HBsAb result and a history of Hepatitis B vaccination is allowed.

  • History of thromboembolic diseases.

  • History of bleeding tendencies.

  • History of myocardial infarction, unstable angina, arterial revascularization,mechanical prosthetic heart valve, stroke, New York Association Functional ClassII-IV heart failure, or transient ischemic attack.

  • Any known allergy or intolerance to midazolam or other drugs in the benzodiazepineclass, and/or to dabigatran etexilate, and/or to OCs.

  • Any medical or psychiatric condition including any active suicidal ideation in thepast year or suicidal behavior in the past 5 years or laboratory abnormality orother conditions that may increase the risk of study participation or, in theinvestigator's judgment, make the participant inappropriate for the study.

  • Use of certain prescription or nonprescription drugs and dietary (e.g. grapefruit)and herbal supplements within up to 14 days or 5 half-lives, whichever is longer,prior to the first dose of study intervention.

  • Recent exposure to live or attenuated vaccines within 28 days of the screeningvisit.

  • History of alcohol abuse or repeated binge drinking and/or any other illicit druguse or dependence within 6 months of screening.

  • Use of tobacco/nicotine containing products in excess of the equivalent of 5cigarettes/day or 2 chews of tobacco/day.

Study Design

Total Participants: 16
Treatment Group(s): 4
Primary Treatment: Portia (EE and LN) or equivalent oral tablet
Phase: 1
Study Start date:
October 03, 2025
Estimated Completion Date:
December 15, 2025

Connect with a study center

  • Pfizer Clinical Research Unit - New Haven

    New Haven 4839366, Connecticut 4831725 06511
    United States

    Site Not Available

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