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Background

What do we already know about this topic?

  • Single doses of lasmiditan, up to 400 mg, in healthy subjects and migraine patients is well characterized, but the safety and tolerability of multiple doses is yet to be established.
  • In-vitro data suggest multiple doses of lasmiditan may induce CYP enzyme activity but this has not previously been studied.

How was this study conducted?

  • A Phase I randomized, double-blind, placebo-controlled study on healthy adults (aged 20–63 years) that evaluated PK through serial blood samples collected at set intervals.
  • Cohort 1 patients (n=40) received probe drug cocktail (PDC) of CYP substrates (caffeine 100 mg, midazolam 2 mg, and tolbutamide 500 mg) on Day -3 and daily oral doses of lasmiditan 200 mg or placebo on Day 1 for 7 days. On Day 7, the PDC was administered with lasmiditan.
  • Cohort 2 patients (n=30) received daily oral doses of lasmiditan 400 mg or placebo for 7 days.