Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Pfizer
Conditions:
Atopic Dermatitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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: *...
Eligibility Criteria
Inclusion
- Female participants ≥18 years of age, at screening who are overtly healthy as determined 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, treatment plan, laboratory tests, and other study procedures.
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic 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). A positive 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 Class II-IV heart failure, or transient ischemic attack.
- Any known allergy or intolerance to midazolam or other drugs in the benzodiazepine class, and/or to dabigatran etexilate, and/or to OCs.
- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator'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 screening visit.
- History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
- Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.
Key Trial Info
Start Date :
October 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT07190430
Start Date
October 3 2025
End Date
December 15 2025
Last Update
December 9 2025
Active Locations (1)
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1
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States, 06511