Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
This study is seeking participants who:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline Midazolam | Other | Participants will receive a single dose of 2 mg midazolam in the morning on Day 1 |
|
| Baseline dabigatran etexilate | Other | Participants will receive a single dose of 150 mg dabigatran etexilate in the morning on Day 1 |
|
| Baseline oral contraceptives | Other | 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 | Experimental | 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 | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08049820 | Drug | Administered orally |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Female participants ≥18 years of age
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | New Haven | Connecticut | 06511 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DDI oral contraceptives | Experimental | 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 |
|
| Midazolam | Drug | Administered orally |
|
| Dabigatran Etexilate | Drug | Administered orally |
|
| Portia (EE and LN) or equivalent oral tablet | Drug | Administered orally |
|
| 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 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D000069604 | Dabigatran |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided