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

Pfizer

Status and phase: Active, not recruiting; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: Dabigatran Etexilate; Drug: Midazolam; Drug: PF-08049820; Drug: Portia (EE and LN) or equivalent oral tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT07190430

C6231004

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 6 patient groups

Baseline Midazolam

Other group

Description:

Participants will receive a single dose of 2 mg midazolam in the morning on Day 1

Treatment:

Drug: Midazolam

Baseline dabigatran etexilate

Other group

Description:

Participants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1

Treatment:

Drug: Dabigatran Etexilate

Baseline oral contraceptives

Other group

Description:

Participants will receive a single dose of Portia (30 mcg of ethinyl estradiol (EE) and 150 mcg of levonorgestrel (LN)) or equivalent oral tablet in the morning on Day 1

Treatment:

Drug: Portia (EE and LN) or equivalent oral tablet

Drug Drug Interaction (DDI) midazolam

Experimental group

Description:

Participants will receive a single dose of 2 mg midazolam in the morning on Days 2 and 10 only with PF-08049820 Days 1 to 10

Treatment:

Drug: Midazolam

Drug: PF-08049820

DDI dabigatran etexilate

Experimental group

Description:

Participants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1 only with PF-08049820 Days 1 to 2

Treatment:

Drug: PF-08049820

Drug: Dabigatran Etexilate

DDI oral contraceptives

Experimental group

Description:

Participants will receive a single dose of Portia (30 mcg of EE and 150 mcg of LN) or equivalent oral tablet in the morning on Day 1 only with PF-08049820 on Days 1 to 2

Treatment:

Drug: Portia (EE and LN) or equivalent oral tablet

Drug: PF-08049820