A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants

Phase 1

Completed

Interventions: Drug: Placebo for Lasmiditan
Drug: Lasmiditan
Drug: Placebo for Sumatriptan
Drug: Sumatriptan

Brief Summary: The purpose of this study is to assess whether taking lasmiditan and sumatriptan together will have any additional effects on heart rate and blood pressure compared to taking lasmiditan and sumatriptan individually. This study will also look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it when these two drugs are taken together.

This study will last about 21 days, not including the screening. Participants will spend 16 days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is required within 28 days prior to the start of the study.

Recruitment & Eligibility

Inclusion Criteria

Are overtly healthy males or females, as determined by medical history and physical examination
Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

Exclusion Criteria

Have known allergies to Lasmiditan, Sumatriptan, related compounds, or any components of the formulations of Lasmiditan and Sumatriptan
Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias
Have a history, signs, or symptoms of arrhythmia or Wolff Parkinson White syndrome that could affect the participant's safety
Have an estimated glomerular filtration rate (eGFR) of less than (<) 60 milliliter per minute (mL/min) per 1.73 m²
Have a resting systolic blood pressure (SBP) greater than (>) 135 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) >85 mmHg at screening
Have a supine pulse rate (PR) of <50 or >90 beats per minute (bpm) at screening
Have a history, signs, or symptoms of vasospastic coronary artery disease
Have known or ongoing neuropsychiatric disorders (for example, manic depressive illness, schizophrenia, depression) considered as clinically significant by the investigator
Use of monoamine oxidase-A inhibitors and other drugs associated with serotonin within the 3 months prior to the first dosing occasion

Arm && Interventions

Group	Intervention	Description
Lasmiditan + Placebo (B)	Placebo for Sumatriptan	Single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet in one of four treatment periods.
Placebo + Placebo (D)	Placebo for Sumatriptan	Oral doses of placebo tablets in one of four treatment periods.
Placebo + Placebo (D)	Placebo for Lasmiditan	Oral doses of placebo tablets in one of four treatment periods.
Sumatriptan + Placebo (C)	Placebo for Lasmiditan	Single oral dose of 100 mg sumatriptan tablet and single oral dose of placebo tablet in one of four treatment periods.
Lasmiditan + Sumatriptan (A)	Sumatriptan	Single oral dose of 200 milligram (mg) lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet in one of four treatment periods.
Lasmiditan + Sumatriptan (A)	Lasmiditan	Single oral dose of 200 milligram (mg) lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet in one of four treatment periods.
Sumatriptan + Placebo (C)	Sumatriptan	Single oral dose of 100 mg sumatriptan tablet and single oral dose of placebo tablet in one of four treatment periods.
Lasmiditan + Placebo (B)	Lasmiditan	Single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet in one of four treatment periods.

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP)	Baseline (Day 1), Day 2	Systolic Blood Pressure (SBP) was measured by using a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least squares (LS) mean peak changes from baseline were calculated using a linear mixed-effects model with baseline, treatment, period, and sequence as fixed effects and participant as a random effect.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0 ∞]) of Lasmiditan and Sumatriptan	Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12, 24 ,36 and 48 h postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose	PK: AUC(0 ∞) of Lasmiditan and Sumatriptan was evaluated.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan and Sumatriptan	Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 , 24 ,36 and 48 hours(h) postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose	PK: Cmax of Lasmiditan and Sumatriptan was evaluated.