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| ID | Type | Description | Link |
|---|---|---|---|
| IRAK4 MAD | Other Identifier | Alias Study Number |
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A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Sequential Group, Multiple Ascending Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Orally Administered PF-06650833 In Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06650833 | Experimental | Active arm , PF-06650833 kinase. |
|
| Placebo | Placebo Comparator | Placebo arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06650833 | Drug | Suspension |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment emergent adverse events. | 50 days | |
| Incidence and Magnitude of Participants with Treatment-emergent hematology clinical abnormalities | 50 days | |
| Incidence and Magnitude of Participants with Treatment-emergent chemistry abnormalities (including, cardiac enzymes CK, CK-MB and cardiac Troponin-1, serum myoglobin) | 50 days | |
| Incidence and Magnitude of Participants with Treatment-emergent urinalysis abnormalities | 50 Days | |
| Changes from baseline in blood pressure | 50 days | |
| Changes from baseline in pulse rate | 50 days | |
| Changes from baseline in respiratory rate | 50 days | |
| Changes from baseline in ECG parameters (standard 12-lead ECG) | 50 days | |
| Changes from baseline in Epstein-Barr virus [EBV] | 50 days | |
| Changes from baseline in Cytomegalovirus [CMV] | 50 days | |
| Changes from baseline in Herpes simplex virus-1 and -2 [HSV-1 and HSV-2] |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize Cmax in plasma | Day 1 and Day 14 | |
| To determine PF-06650833 excreted unchanged (AE tau and AE tau %), | Day 14 | |
| To characterize Tmax in plasma |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34423919 | Derived | Winkler A, Sun W, De S, Jiao A, Sharif MN, Symanowicz PT, Athale S, Shin JH, Wang J, Jacobson BA, Ramsey SJ, Dower K, Andreyeva T, Liu H, Hegen M, Homer BL, Brodfuehrer J, Tilley M, Gilbert SA, Danto SI, Beebe JJ, Barnes BJ, Pascual V, Lin LL, Kilty I, Fleming M, Rao VR. The Interleukin-1 Receptor-Associated Kinase 4 Inhibitor PF-06650833 Blocks Inflammation in Preclinical Models of Rheumatic Disease and in Humans Enrolled in a Randomized Clinical Trial. Arthritis Rheumatol. 2021 Dec;73(12):2206-2218. doi: 10.1002/art.41953. Epub 2021 Nov 1. | |
| 31805989 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| Drug |
Suspension |
|
| PF-06650833 | Drug | Tablet (Modified Release) |
|
| Placebo | Drug | Tablet (Modified Release) |
|
| 50 days |
| Day 1 and Day 14 |
| To characterize AUC tau in plasma | Day 1 and Day 14 |
| To characterize Cmin in plasma | Day 1 and Day 14 |
| Characterize Cmax (dose normalized) in plasma | Day 1 and Day 14 |
| To characterize AUC tau(dose normalized) in plasma | day1 and day 14 |
| To determine the renal clearance (CLr) | Day 14 |
| 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. |