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The purpose of this study is to learn how different forms of the study medicine called PF-08049820 are absorbed and eliminated in healthy adults. The study will assess whether the study medicine is absorbed differently when taken with or without food. It will also assess absorption when the study medicine is taken with another medicine called rabeprazole. Rabeprazole is an FDA approved medicine that reduces stomach acid.
The study has two parts. In Part A, participants will take three forms of study medicine, one after the other. They will take each form either with or without food for a total of five doses. Each dose will be separated by a few days. Participants will stay in the clinic for about two weeks. They will receive a telephone follow-up call about a month after the last dose.
In Part B, participants will take three forms of study medicine. They will take each one with or without food, and with or without another medicine called rabeprazole. This means they will take a total of six doses of study medicine. Each dose will be separated by a few days. Participants will stay at the clinic for about three weeks, and about a month after their last dose. They will get a follow-up phone call. Part B may or may not be conducted depending on the results from Part A.
The study is seeking participants who:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
|
| Sequence 2 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
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| Sequence 3 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
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| Sequence 4 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
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| Sequence 5 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
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| Sequence 6 (Part A) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08049820 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | Part A: Evaluate the relative bioavailability of different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820. | Baseline up to Day 16 for Part A and up to Day 24 for optional Part B |
| Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit | Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820. | Baseline up to Day 16 for Part A and up to Day 24 for optional Part B |
| Maximum observed plasma concentration (Cmax) | Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820. | Baseline up to Day 16 for Part A and up to Day 24 for optional Part B |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Part A and optional Part B | Baseline up to Day 48 for Part A and up to Day 56 for optional Part B |
| Number of Participants With Serious Adverse Events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | Recruiting | 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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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
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| Sequence 7 (Optional Part B) | Experimental | 3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions. |
|
| Rabeprazole | Drug | Administered orally |
|
Part A and optional Part B
| Baseline up to Day 48 for Part A and up to Day 56 for optional Part B |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Part A and optional Part B | Baseline up to Day 16 for Part A and up to Day 24 for optional Part B |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Part A and optional Part B | Baseline up to Day 16 for Part A and up to Day 24 for optional Part B |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | Part A and optional Part B | Baseline up to Day 16 for Part A and up to Day 24 for optional Part B |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820. | Baseline up to Day 16 for Part A |
| Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit | Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820. | Baseline up to Day 16 for Part A |
| Maximum observed plasma concentration (Cmax) | Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820. | Baseline up to Day 16 for Part A |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |