Skip to main content

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

 

Placeboa

PF-06650833 dose group

IR 1 mg

IR 3 mg

IR 10 mg

IR 30 mg

IR 30 mg (fed)

IR 100 mg

IR 100 mgb

IR 300 mg

IR 1000 mg

IR 2000 mg (fed)

IR 6000 mg (fed)

MR 30 mg

MR 30 mg (fed)

MR 100 mg

MR 300 mg

Subjects evaluable for AEs

31

8

8

8

15

8

8

8

8

8

8

8

8

8

8

8

Subjects with AEs

4 (0)

1 (0)

0

0

0

1 (1)

1 (0)

2 (1)

0

2 (0)

3 (1)

2 (1)

0

0

1 (0)

2 (0)

Number of AEs

6 (0)

1 (0)

0

0

0

1 (1)

1 (0)

10 (7)

0

3 (0)

4 (1)

2 (1)

0

0

1 (0)

4 (0)

Number of subjects with AEs by system organ class and preferred term

 Ear and labyrinth disorders

1 (0)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

  Vertigo

1 (0)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 Gastrointestinal disorders

1 (0)

0

0

0

0

0

0

1 (1)

0

0

1 (0)

0

0

0

0

1 (0)

  Abdominal discomfort

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1 (0)

  Abdominal distension

0

0

0

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

  Abdominal pain

0

0

0

0

0

0

0

1 (1)

0

0

0

0

0

0

0

0

  Diarrhea

0

0

0

0

0

0

0

1 (1)

0

0

0

0

0

0

0

1 (0)

  Dry mouth

0

0

0

0

0

0

0

1 (1)

0

0

0

0

0

0

0

0

  Enterocolitis

1 (0)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

  Flatulence

0

0

0

0

0

0

0

1 (1)

0

0

0

0

0

0

0

0

 General disorders and administration site conditions

1 (0)

0

0

0

0

0

0

1 (1)

0

0

0

0

0

0

0

0

  Fatigue

0

0

0

0

0

0

0

1 (1)

0

0

0

0

0

0

0

0

  Pain

1 (0)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 Infections and infestations

0

1 (0)

0

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

  Conjunctivitis

0

1 (0)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

  Folliculitis

0

0

0

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

  Upper respiratory tract infection

0

0

0

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

 Injury, poisoning, and procedural complications

0

0

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

0

  Fall

0

0

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

0

 Metabolism and nutrition disorders

0

0

0

0

0

0

0

1 (1)

0

0

0

0

0

0

0

0

  Decreased appetite

0

0

0

0

0

0

0

1 (1)

0

0

0

0

0

0

0

0

 Musculoskeletal and connective tissue disorders

1 (0)

0

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

1 (0)

  Arthralgia

0

0

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

0

  Musculoskeletal stiffness

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1 (0)

  Neck pain

1 (0)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 Nervous system disorders

1 (0)

0

0

0

0

0

0

1 (1)

0

1 (0)

1 (1)

2 (1)

0

0

0

0

  Dizziness

0

0

0

0

0

0

0

1 (1)

0

0

0

1 (0)

0

0

0

0

  Headache

1 (0)

0

0

0

0

0

0

0

0

1 (0)

1 (1)

1 (1)

0

0

0

0

 Psychiatric disorders

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1 (0)

0

  Anxiety

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1 (0)

0

 Respiratory, thoracic, and mediastinal disorders

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

0

0

0

  Hypopnea

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

0

0

0

 Skin and subcutaneous tissue disorders

1 (0)

0

0

0

0

1 (1)

1 (0)

1 (0)

0

0

0

0

0

0

0

1 (0)

  Acne

0

0

0

0

0

1 (1)

0

0

0

0

0

0

0

0

0

0

  Dermatitis contact

1 (0)

0

0

0

0

0

1 (0)

0

0

0

0

0

0

0

0

0

  Erythema

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

0

0

0

  Scab

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1 (0)

  Skin irritation

0

0

0

0

0

0

0

1 (0)

0

0

0

0

0

0

0

0

  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