A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo for Sumatriptan; Drug: Sumatriptan; Drug: Placebo for Lasmiditan; Drug: Lasmiditan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03310411

16926

H8H-MC-LAHU (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Lasmiditan + Sumatriptan (A)

Experimental group

Description:

Single oral dose of 200 milligram (mg) lasmiditan tablet and single oral dose of 100 mg sumatriptan tablet in one of four treatment periods.

Treatment:

Drug: Lasmiditan

Drug: Sumatriptan

Lasmiditan + Placebo (B)

Experimental group

Description:

Single oral dose of 200 mg lasmiditan tablet and single oral dose of placebo tablet in one of four treatment periods.

Treatment:

Drug: Lasmiditan

Drug: Placebo for Sumatriptan

Sumatriptan + Placebo (C)

Active Comparator group

Description:

Single oral dose of 100 mg sumatriptan tablet and single oral dose of placebo tablet in one of four treatment periods.

Treatment:

Drug: Placebo for Lasmiditan

Drug: Sumatriptan

Placebo + Placebo (D)

Placebo Comparator group

Description:

Oral doses of placebo tablets in one of four treatment periods.

Treatment:

Drug: Placebo for Lasmiditan

Drug: Placebo for Sumatriptan