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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Administered orally
Administered orally
Administered orally
Administered orally
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States
Pharmacokinetics (PK): Area Under the curve (AUC) of Midazolam
Time frame: From pre-dose up to 24 hours post dose in Periods 1 and 4
PK: Plasma Maximum Concentration (Cmax) of Midazolam
Time frame: From pre-dose up to 24 hours post dose in Periods 1 and 4
PK: Area Under the curve (AUC) of dabigatran
Time frame: From pre-dose up to 48 hours post dose in Periods 2 and 5
PK: Cmax of dabigatran
Time frame: From pre-dose up to 48 hours post dose in Periods 2 and 5
PK: AUC of Ethinyl estradiol and levonorgestrel
Time frame: From pre-dose up to 96 hours post dose in Periods 3 and 6
PK: Cmax of Ethinyl estradiol and levonorgestrel
Time frame: From pre-dose up to 96 hours post dose in Periods 3 and 6
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: First dose of study intervention until Follow Up Visit (28 to 35 days after the last dose)
Number of Participants With Clinically Significant Change from Baseline in Laboratory Abnormalities
Time frame: Baseline to Study Day 24
Number of Participants With Clinically Significant Change from Baseline in Vital Signs
Time frame: Baseline to Study Day 24
Number of Participants With Clinically Significant Change from Baseline in 12-lead Electrocardiogram (ECG) Findings
Time frame: Baseline to Study Day 24
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