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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002052-88 | EudraCT Number |
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Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relative Bioavailability Cohort | Other | Relative Bioavailability cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06650833 | Drug | Two formulations of PF-006650833 |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 0-96 hours | |
| AUClast | 0-96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax under high fat meal fed conditions | 0-96 hours | |
| Pharmacokinetic parameters of PF-06650833 from plasma concentration (if data permits) | 0-96 hours | |
| AUClast under high fat meal fed conditions |
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Inclusion Criteria:
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any condition possibly affecting drug absorption (eg, gastrectomy).
History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
-Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality
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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 | Brussels | B-1070 | Belgium |
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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 |
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| 0-96 hours |