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Table 1 Study 1 (SAD) TEAEs. All causalities (treatment-related)

From: 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

 PlaceboaPF-06650833 dose group
IR 1 mgIR 3 mgIR 10 mgIR 30 mgIR 30 mg (fed)IR 100 mgIR 100 mgbIR 300 mgIR 1000 mgIR 2000 mg (fed)IR 6000 mg (fed)MR 30 mgMR 30 mg (fed)MR 100 mgMR 300 mg
Subjects evaluable for AEs318881588888888888
Subjects with AEs4 (0)1 (0)0001 (1)1 (0)2 (1)02 (0)3 (1)2 (1)001 (0)2 (0)
Number of AEs6 (0)1 (0)0001 (1)1 (0)10 (7)03 (0)4 (1)2 (1)001 (0)4 (0)
Number of subjects with AEs by system organ class and preferred term
 Ear and labyrinth disorders1 (0)000000000000000
  Vertigo1 (0)000000000000000
 Gastrointestinal disorders1 (0)0000001 (1)001 (0)00001 (0)
  Abdominal discomfort0000000000000001 (0)
  Abdominal distension00000000001 (0)00000
  Abdominal pain00000001 (1)00000000
  Diarrhea00000001 (1)00000001 (0)
  Dry mouth00000001 (1)00000000
  Enterocolitis1 (0)000000000000000
  Flatulence00000001 (1)00000000
 General disorders and administration site conditions1 (0)0000001 (1)00000000
  Fatigue00000001 (1)00000000
  Pain1 (0)000000000000000
 Infections and infestations01 (0)000000001 (0)00000
  Conjunctivitis01 (0)00000000000000
  Folliculitis00000000001 (0)00000
  Upper respiratory tract infection00000000001 (0)00000
 Injury, poisoning, and procedural complications0000000001 (0)000000
  Fall0000000001 (0)000000
 Metabolism and nutrition disorders00000001 (1)00000000
  Decreased appetite00000001 (1)00000000
 Musculoskeletal and connective tissue disorders1 (0)000000001 (0)000001 (0)
  Arthralgia0000000001 (0)000000
  Musculoskeletal stiffness0000000000000001 (0)
  Neck pain1 (0)000000000000000
 Nervous system disorders1 (0)0000001 (1)01 (0)1 (1)2 (1)0000
  Dizziness00000001 (1)0001 (0)0000
  Headache1 (0)000000001 (0)1 (1)1 (1)0000
 Psychiatric disorders000000000000001 (0)0
  Anxiety000000000000001 (0)0
 Respiratory, thoracic, and mediastinal disorders00000001 (0)00000000
  Hypopnea00000001 (0)00000000
 Skin and subcutaneous tissue disorders1 (0)00001 (1)1 (0)1 (0)00000001 (0)
  Acne000001 (1)0000000000
  Dermatitis contact1 (0)000001 (0)000000000
  Erythema00000001 (0)00000000
  Scab0000000000000001 (0)
  Skin irritation00000001 (0)00000000
  1. All doses were administered orally under fasting conditions (overnight fast of ≥ 10 h) unless otherwise indicated. Fed doses were administered after consumption of a high-fat breakfast. Subjects were counted only once per treatment in each row. The table includes all data collected since the first dose of study drug
  2. AE adverse event, IR immediate-release, MR modified-release, SAD single ascending doses, TEAE treatment-emergent AE
  3. aRepresents placebo groups (IR placebo, IR fed placebo, MR placebo, and MR fed placebo) in all cohorts
  4. bAlternate IR formulation