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| ID | Type | Description | Link |
|---|---|---|---|
| IRAK4 FIH | Other Identifier | Alias Study Number |
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This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals are to assess the safety, tolerability and blood levels of ascending doses of multiple formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on exposure, in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (1-1000mg) Immediate Release formulation | Experimental |
| |
| Immediate Release Placebo arm | Placebo Comparator |
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| (10-500) mg Modified Release formulation | Experimental |
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| Modified Release Placebo arm | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06650833 | Drug | Subjects will receive sequential single escalating doses of 1-1000 mg of Immediate Release of PF-06650833 (as solution/suspension) under fed and / or fasted conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events | Baseline-5 days | |
| Changes from baseline in vital signs ( blood pressure, pulse rate, respiratory rate and orthostatic blood pressure) | Baseline-5 days | |
| Changes from baseline in ECG parameters (standard 12 lead ECG and telemetry) | Quantitative changes in ECG intervals | Baseline-5 days |
| Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry (including, cardiac enzymes CK, CK MB and cardiac Troponin I), serum myoglobin, urinalysis | Baseline-5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, Cmax(dn), AUCinf(dn), AUClast(dn), t½, mean residence time (MRT) for IR and MR formulations under fasted condition | Baseline-5 days | |
| Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, Cmax(dn), AUCinf(dn), AUClast(dn), t½, mean residence time (MRT) for IR and MR formulations under fed condition |
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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 |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31805989 | Derived | Danto SI, Shojaee N, Singh RSP, Li C, Gilbert SA, Manukyan Z, Kilty I. Safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06650833, a selective interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor, in single and multiple ascending dose randomized phase 1 studies in healthy subjects. Arthritis Res Ther. 2019 Dec 5;21(1):269. doi: 10.1186/s13075-019-2008-6. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo | Drug | Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as solution/suspension) under fed and/ or fasted conditions. |
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| PF-06650833 | Drug | Subjects will receive sequential single escalating doses of 10-500 mg of Modified Release of PF-06650833 (as capsule) under fed and / or fasted conditions. |
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| Placebo | Drug | Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as capsule) under fed and/ or fasted conditions. |
|
| Baseline-5 days |
| ID | Term |
|---|---|
| C000621967 | 1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide |
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