A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03310411

Run by

Eli Lilly and Company

People needed

40

Starts

2017-10-17

Expected to finish

2017-12-23

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance Daytona Beach — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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