Atopic Dermatitis
Conditions
Keywords
Healthy Volunteers
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.
Interventions
DRUGPF-08049820
Administered orally
DRUGMidazolam
Administered orally
DRUGDabigatran Etexilate
Administered orally
DRUGPortia (EE and LN) or equivalent oral tablet
Administered orally
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed