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Table 1 Summary of treatment-emergent adverse events by frequency and preferred term

From: Lucerastat, an iminosugar with potential as substrate reduction therapy for glycolipid storage disorders: safety, tolerability, and pharmacokinetics in healthy subjects

Single ascending dose study
  Lucerastat 100 mg (n = 6) Lucerastat 300 mg (n = 6) Lucerastat 500 mg (n = 6) Lucerastat 1000 mg (n = 6) Lucerastat 2 x 1000 mg (n = 6) Placebo Overall (n = 9) Lucerastat Overall (n = 24)
Number of subjects with at least one AE 2 2 0 1 4 1 9
Total number of AEs 2 2 0 1 9 1 14
Preferred term
   Fatigue - - - - 1 - 1
   Influenza like illness 1 - - - - - 1
   Constipation - - - 1 - - 1
   Abdominal upper pain - - - - 1 - 1
   Back pain - - - - 1 - 1
   Neck stiffness - - - - 1 - 1
   Cough - - - - 2 - 2
   Hot flushes - - - - - 1 -
   Headache - - - - 2 - 2
   Paresthesia 1 - - - - - 1
   Somnolence - - - - 1 - 1
   Rash NOS - 2 - - - - 2
Multiple ascending dose study
  Lucerastat 200 mg (n = 6) Lucerastat 500 mg (n = 12) Lucerastat 1000 mg (n = 6) Placebo Overall (n = 13) Lucerastat Overall (n = 24)   
Number of subjects with at least one AE 3 6 1 5 10   
Total number of AEs 3 7 3 5 13   
Preferred term
   Lymphadenitis submandibular - 1 - - 1   
   Aphthous stomatitis - - 1 - 1   
   Constipation 1 - - - 1   
   Diarrhea - 1 - - 1   
   Dyspepsia 1 - - 2 1   
   Toothache 1 - - - 1   
   Nasopharyngitis - 1 - - 1   
   ALT increased - 3 - 1 3   
   AST increased - 1 - - 1   
   Dizziness - - - 1 -   
   Headache - - 1 - 1   
   Rash NOS - - 1 1 1   
  1. AE Adverse Events, Coding details according to MedDRA version 14.0; NOS Not otherwise specified