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
Not provided
Not provided
Study has two arms. Arm 1 has two cohorts in which each cohort, under the fasted state, will either be given a single oral dose of Form 1 in Period 1 followed by a single oral dose of Form 5 in Period 2 or a single oral dose of Form 5 in Period 1 followed by a single oral dose of Form 1 in Period 2. A single oral dose of Form 1 will be administered in Arm 2 Period 1 under the fasted state. The results from Arm 1 will inform whether a different dose of Form 5 will be administered under the fasted state or if Form 5 will be administered under the fed state in Arm 2 Period 2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07248144 Form 1 (uncoated) Arm | Experimental | Period 1: Participants received Form 1 in a single dose of tablet fasted Period 2: Participants received Form 5 in a single dose of tablet fasted |
|
| PF-07248144 Form 5 (film-coated) Arm | Experimental | Period 1: Participants received Form 5 in a single dose of tablet fasted Period 2: Participants received Form 1 in a single dose of tablet fasted |
|
| PF-07248144 Form 5 (film-coated) Adaptive Arm | Experimental | Period 1: Fasted participants received a single dose of tablet of Form 1 orally Period 2: Participants received a single dose of tablet orally of Form 5 in a fed state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07248144 | Drug | Period 1: Participants received Form 1 in a single dose of tablet fasted Period 2: Participants received Form 5 in a single dose of tablet fasted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07248144 Form 1 uncoated tablet | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose | |
| AUCinf for PF-07248144 Form 5 film-coated tablet | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose | |
| Maximum Observed Plasma Concentration (Cmax) for PF-07248144 Form 1 uncoated tablet | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose | |
| Cmax for PF-07248144 Form 5 film-coated tablet | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment Related AEs and SAEs | From Baseline up to Day 35 | |
| Number of Participants With Laboratory Test Abnormalities | From Baseline up to Day 35 | |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
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
| PF-07248144 | Drug | Period 1: Participants received Form 5 in a single dose of tablet fasted Period 2: Participants received Form 1 in a single dose of tablet fasted |
|
| PF-07248144 | Drug | Period 1: Fasted participants received a single dose of tablet of Form 1 orally Period 2: Participants received a single dose of tablet orally of Form 5 in a fed state |
|
| Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria |
| From Baseline up to Day 35 |
| Number of Participants With Clinically Significant Physical Examination Abnormalities | From Baseline up to Day 35 |