Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Pediatric Patients with Migraine.

ABSTRACT:

Introduction

Lasmiditan is a selective serotonin (5-HT1F) receptor agonist approved in the US for the acute treatment ofmigraine in adults. This phase I, open-label, two-cohort study assessed the pharmacokinetics (PK), safety, and tolerability of lasmiditan in patients with migraine aged 6 to < 18 years.

Methods

Cohort 1 (15 to ≤ 40 kg) and Cohort 2 (> 40 to ≤ 55 kg) received single oral doses of lasmiditan (100 mg and 200 mg, respectively).Blood samples for the assessment of PK and safety parameters were collected over a 24-h period. Follow-up was approximately 14 days after dosing.

Results

Eighteen patients received lasmiditan (11 in Cohort 1, 7 in Cohort 2) and 17 patients completed the study. One patient in Cohort 2 discontinued due to adverse events. Plasma conce

SUBMITTER: Tsai M 

PROVIDER: S-EPMC8195962 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature