This multicenter single-dose study determined lasmiditan’s pharmacokinetics, safety, and tolerability in pediatric patients aged 6 to <18 years with migraine.

Lasmiditan is a selective serotonin (5-HT_1F) receptor agonist approved in the US for acute treatment of migraine with or without aura in adults.

Study was conducted in the US and Japan. Cohort 1 (body weight 15 to ≤40kg) and 2 (body weight >40 to ≤55kg) received 100mg and 200mg lasmiditan, respectively. This weight-based dosing was expected to elicit exposures in pediatric patients comparable to adults receiving 200mg dose. Study procedures were conducted while patients were migraine-free. Blood samples for assessment of PK and safety parameters were collected over a 24-hour (h) period. Parameters included maximum concentration (C_max), time to maximum concentration, and area under the concentration curve (AUC).

Of 18 patients receiving lasmiditan (cohort 1:11, cohort 2:7), 17 completed the study and 1 (cohort 2) discontinued due to AEs.

Following administration, the time course of lasmiditan concentrations was similar for patients receiving 100mg/200mg. Plasma concentrations peaked at median C_max time=1.5-2.0 h postdose and then declined with geometric mean terminal half-life=~4.0 h, similar to adult subjects. While exposure to lasmiditan expressed by C_max and AUC was generally similar between cohorts, geometric mean values for apparent total body clearance of drug calculated after oral administration and apparent volume of distribution during terminal phase after oral administration were greater for 200-mg vs 100-mg cohort, as this reflects differences in dose and body weight in the cohorts.

No deaths or serious AEs were reported. Frequency and severity of AEs (including somnolence, dizziness, and fatigue) were similar as in adult lasmiditan studies.

PK results support weight-based dosing of lasmiditan in pediatric migraine patients. No new safety issues were identified in this study population.