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
Not Applicable
Not yet recruiting
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: Portia (EE and LN) or equivalent oral tablet
- Registration Number
- NCT07190430
- Lead Sponsor
- Pfizer
- 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:
* 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 16
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 oral contraceptive hormones (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Baseline Midazolam Midazolam Participants will receive a single dose of 2 mg midazolam in the morning on Day 1 Baseline dabigatran etexilate Dabigatran Etexilate Participants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1 Baseline oral contraceptives Portia (EE and LN) or equivalent oral tablet 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 Drug Drug Interaction (DDI) midazolam PF-08049820 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 Drug Drug Interaction (DDI) midazolam Midazolam 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 DDI dabigatran etexilate PF-08049820 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 DDI dabigatran etexilate Dabigatran Etexilate 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 DDI oral contraceptives PF-08049820 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 DDI oral contraceptives Portia (EE and LN) or equivalent oral tablet 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
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the curve (AUC) of Midazolam From pre-dose up to 24 hours post dose in Periods 1 and 4 PK: Plasma Maximum Concentration (Cmax) of Midazolam From pre-dose up to 24 hours post dose in Periods 1 and 4 PK: Area Under the curve (AUC) of dabigatran From pre-dose up to 48 hours post dose in Periods 2 and 5 PK: Cmax of dabigatran From pre-dose up to 48 hours post dose in Periods 2 and 5 PK: AUC of Ethinyl estradiol and levonorgestrel From pre-dose up to 96 hours post dose in Periods 3 and 6 PK: Cmax of Ethinyl estradiol and levonorgestrel From pre-dose up to 96 hours post dose in Periods 3 and 6
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Change from Baseline in Laboratory Abnormalities Baseline to Study Day 24 Number of Participants With Clinically Significant Change from Baseline in Vital Signs Baseline to Study Day 24 Number of Participants With Clinically Significant Change from Baseline in 12-lead Electrocardiogram (ECG) Findings Baseline to Study Day 24 Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) First dose of study intervention until Follow Up Visit (28 to 35 days after the last dose)