drugset / Trial / NCT03012334

The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants

NCT03012334

RandomizedCrossoverTriple-blindOther

Summary

This will be a randomized, single dose, double-blind, placebo-controlled, Latin-square design with 5-period (full) crossover study with participants randomized to treatment sequences. Participants will complete all 5 Periods. During each Period, participants will come to the clinical research unit (CRU) and remain overnight before being dosed with a single dose of either lasmiditan, alprazolam, or placebo in the morning. Cognitive testing and driving simulation will be conducted post dosing. Participants will have a washout of at least 5 days between each Period. This study is designed to test non-inferiority of lasmiditan doses relative to placebo, with an alprazolam test versus placebo to confirm the sensitivity of the simulator to detect treatment effects.

Timeline

Start
2017-01-16
Primary completion
2017-06-08
Completion
2017-06-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alprazolam Small molecule 1 mg Oral
Subject Lasmiditan Small molecule 50 mg Oral
Subject Lasmiditan Small molecule 100 mg Oral
Subject Lasmiditan Small molecule 200 mg Oral

Indications