Phase
Condition
Atopic Dermatitis
Dermatitis, Atopic
Eczema (Atopic Dermatitis)
Treatment
Portia (EE and LN) or equivalent oral tablet
PF-08049820
Midazolam
Clinical Study ID
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Pfizer Clinical Research Unit - New Haven
New Haven 4839366, Connecticut 4831725 06511
United StatesSite Not Available

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