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The purpose of this study is to understand bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of the current PF-07220060 tablet formulation and the proposed higher drug load tablet that is already available in the market.
The study is seeking participants who are:
Participants in the study will receive a single dose of PF-07220060 by mouth after a meal, following at least 7 days, the participant will then receive another dose of PF-07220060. Each dose received by the participant will be a different tablet formulation, and the sequence of tablet formulations given will be random (just like a flipside of the coin).
The study will help the team understand how the difference in tablet formulation may, or may not, affect how the medicine is absorbed, processed, and removed by the body.
Participants will remain in the study clinic for at least 13 days and will have one follow-up contact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A; Treatment Sequence A | Experimental | Single Oral Dose of reference tablet formulation PF-07220060, then at least 7 day washout, followed by a single oral dose of test tablet formulation PF-07220060 |
|
| Regimen B; Treatment Sequence B | Experimental | Single Oral Dose of test tablet formulation PF-07220060, then at least 7 day washout, followed by a single oral dose of reference tablet formulation PF-07220060 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07220060 | Drug | Cyclin-dependent kinase-4 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast)) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data does not permit AUCinf) | AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (If data does not permit reporting of AUCinf). The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages. | Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2 |
| Area under the Plasma Concentration-Time profile (AUC) from time 0 extrapolated to extrapolated infinite time (AUCinf) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data permits). | AUCinf was area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf , if data permits). It is obtained from AUC (0-t) plus AUC (t-inf). The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages. | Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2 |
| Maximum Observed Plasma Concentration (Cmax) profile of test and reference atirmociclib formulations after a high fat/high calorie meal | Cmax was the maximum observed plasma concentration directly observed from data. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages. | Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters | From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2) | |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) |
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Inclusion:
Exclusion:
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| 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 |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2) |
| Number of Participants with Clinically Significant Abnormalities in Vital Signs | From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2) |
| Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities | From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2) |