The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants
Status:
Completed
Trial end date:
2017-06-08
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
CoLucid Pharmaceuticals Eli Lilly and Company
Collaborators:
Algorithme Pharma Inc Cognitive Research Corporation CoLucid Pharmaceuticals