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The purpose of this study is to evaluate the potential pharmacokinetic (PK) drug-drug interaction (DDI) between PF-06650833 and PF-06651600 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | The study will have only one study group in a fixed-sequence type of design with two periods |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06650833 alone | Drug | In Period 1, Days 1-5, participants will receive PF-06650833 once daily alone. |
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| Measure | Description | Time Frame |
|---|---|---|
| PF-06650833 Cmax | Maximum observed concentration (Cmax) derived from plasma | Fold-change from Period 1/Day 5 to Period 2/Day 12 |
| PF-06650833 AUCtau | Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing. | Fold-change from Period 1/Day 5 to Period 2/Day 12 |
| PF-06651600 Cmax | Maximum observed concentration (Cmax) derived from plasma | Fold-change from Period 2/Day 7 to Period 2/Day 12 |
| PF-06651600 AUCtau | Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing. | Fold-change from Period 2/Day 7 to Period 2/Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with treatment emergent adverse events | From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days) | |
| Percentage of participants with clinical laboratory test results above/below certain threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer 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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| ID | Term |
|---|---|
| C000621967 | 1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide |
| C000614924 | PF-06651600 |
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This is a Phase I, open label, fixed sequence study. The study will consist of 2 periods in a single fixed sequence. In Period 1, participants will receive PF-06650833 once daily on Days 1-5 and PF-06650833 PK will be assessed for 24 hours following Day 5 dosing. Participants will be discharged on Day 6 after completion of study related activities. There will be a washout period of at least 7 days between last dosing in Period 1 and first dosing in Period 2. In Period 2, participants will receive PF-06651600 once daily alone on Days 1-7, and PF-06651600 once daily together with PF-06650833 once daily on Days 8-12. PF-06651600 PK will be assessed for 24 hours following Day 7 dosing, while PK for both PF-06651600 and PF-06650833 will be assessed for 24 hours following Day 12 dosing. Across both periods few additional pre-dose (trough) PK samples will be collected. Participants will remain in the unit up to Day 13 when they will be discharged after completion of study related activities.
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| PF-06651600 alone | Drug | In Period 2, Days 1-7, participants will receive PF-06651600 once daily alone. |
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| PF-06650833 together with PF-06651600 | Drug | In Period 2, Days 8-12, participants will receive PF-06650833 once daily together with PF-06650833 once daily. |
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| At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2 |
| Percentage of participants with vital signs above/below certain threshold | At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2 |
| Percentage of participants with 12-lead electrocardiogram (ECG) results above/below certain threshold | At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2 |