The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |