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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05923411 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to compare multiple formulations of PF-07220060 in terms of their uptake into the blood stream. The study will assess the effects of food and Rabeprazole on the uptake of PF-07220060. Rabeprazole belongs to a type of medications called proton pump inhibitors. In reality, some patients may take both PF-07220060 and rabeprazole together.
This study is seeking participants that are:
- Healthy male or female aged 18 to 65 years
Participants in this study will receive PF-07220060 once or twice by mouth. The participants may receive different tablets for PF-07220060. Some participants will take a meal before receiving PF-07220060. In addition, some participants will take rabeprazole by mouth for 7 days before taking PF-07220060.
The study will compare experiences of people receiving different formulations of PF-07220060. Experiences of people taking food and rabeprazole with PF-07220060 will be compared to those on PF-07220060 alone. This will help understand how much PF-07220060 is taken up into the blood. It will also help understand how meal and Rabeprazole medicine changes the uptake of PF-07220060 into the blood.
Participants will take part in the study for a maximum of 74 days. During this time, they will have to stay onsite for 5 to 13 days. There will be up to 2 onsite study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive PF-07220060 tablet by mouth |
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| Cohort 2 | Experimental | Participants will receive PF-07220060 tablet by mouth |
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| Cohort 3 | Experimental | Participants will receive PF-07220060 tablet by mouth |
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| Cohort 4 | Experimental | Participants will receive PF-07220060 tablet by mouth |
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| Cohort 5 | Experimental | Participants will receive PF-07220060 tablet by mouth |
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| Cohort 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose of PF-07220060 as first Tablet Formulation | Drug | A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time(AUCinf) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose | |
| Maximum Observed Plasma Concentration (Cmax) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose | |
| Cmax of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level |
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Inclusion Criteria:
Exclusion Criteria:
Prior/Concomitant Therapy:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | 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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Participants will receive PF-07220060 and Rabeprazole tablets by mouth
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| Cohort 7 | Experimental | Participants will receive PF-07220060 and Rabeprazole tablet by mouth |
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| Cohort 8 | Experimental | Participants will receive PF-07220060 tablet by mouth |
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| Single dose of PF-07220060 as second Tablet Formulation | Drug | A single dose of PF-0720060 as the second Tablet Formulation administered under fasting conditions |
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| Single dose of PF-07220060 as first Tablet Formulation | Drug | A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions at a second dose level |
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| Single dose of PF-07220060 as second Tablet Formulation | Drug | A single dose of PF-07220060 as the second Tablet Formulation administered under fasting conditions at a second dose level |
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| Single dose of PF-07220060 as a Tablet Formulation | Drug | A single dose of PF-07220060 as a tablet formulation administered under fed conditions |
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| Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration | Drug | A 2-treatment fixed sequence of single dose of PF-07220060 tablets under fasting conditions followed by a single dose of PF-07220060 tablets under Proton Pump Inhibitor (PPI) administration under fasting condition (following a 7 day oral rabeprazole tablets daily administration). |
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| Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration | Drug | A 2-treatment fixed sequence of a single dose of PF-07220060 tablet given with moderate-fat, standard-calorie meal followed by a single dose of PF-07220060 tablet given with moderate-fat, standard-calorie meal and under PPI administration (following a 7 day oral rabeprazole tablets daily administration) |
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| Single dose of PF-07220060 as third tablet formulation | Drug | A 2-period randomized 2-sequence cross over of a single dose of PF-07220060 as first and third tablet formulation under fasting conditions with a 6-day washout in between them |
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| 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose |
| Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time(AUCinf) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations (third formulation) | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours PF-07220060 post-dose |
| Maximum Observed Plasma Concentration (Cmax) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations (third formulation) | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours PF-07220060 post-dose |
| AUCinf of PF-07220060 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a PF-07220060 tablet formulation | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose |
| Cmax of PF-07220060 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a PF-07220060 tablet formulation | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose |
| AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose |
| Cmax of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose |
| AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose |
| Cmax of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition | 0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose |
| Number of Participants With Laboratory Abnormalities | From baseline up to 28 days after PF-07220060 dose |
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings | From baseline up to 28 days after PF-07220060 |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | From baseline up to 28 days after PF-07220060 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | From baseline up to 28 days after PF-07220060 dose |