Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03252015 | A Study of Multiple Doses of Lasmiditan in Healthy Participants | PHASE1 | COMPLETED | 70 | — | — | Aug 15, 2017 | Jan 2, 2018 | Jan 10, 2020 | 1 | United States |
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Probe Drug Cocktail (Cohort 1a) | EXPERIMENTAL | Probe Drug Cocktail administered orally on Day -3. |
| 200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1) | EXPERIMENTAL | 200 mg lasmiditan administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7. |
| Placebo+Probe Drug Cocktail (Cohort 1b) | PLACEBO_COMPARATOR | Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7. |
| 400 mg Lasmiditan (Cohort 2a) | EXPERIMENTAL | 400 mg lasmiditan administered orally for 7 days. |
| Placebo (Cohort 2b) | EXPERIMENTAL | Placebo administered orally for 7 days. |
| Name | Type | Description |
|---|---|---|
| Probe Drug Cocktail | DRUG | Administered orally |
| Lasmiditan | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: * Healthy males or females, as determined by medical history and physical examination * Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening Exclusion Criteria: * Have participated, within the last 30 days, in a c...