A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-17

Study Completion Date

2017-12-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lasmiditan + Sumatriptan (A)

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

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

Administered orally

Sumatriptan

Intervention Type DRUG

Administered orally

Lasmiditan + Placebo (B)

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

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

Administered orally

Placebo for Sumatriptan

Intervention Type DRUG

Administered orally

Sumatriptan + Placebo (C)

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

Group Type ACTIVE_COMPARATOR

Sumatriptan

Intervention Type DRUG

Administered orally

Placebo for Lasmiditan

Intervention Type DRUG

Administered orally

Placebo + Placebo (D)

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

Group Type PLACEBO_COMPARATOR

Placebo for Lasmiditan

Intervention Type DRUG

Administered orally

Placebo for Sumatriptan

Intervention Type DRUG

Administered orally

Interventions

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Lasmiditan

Administered orally

Intervention Type DRUG

Sumatriptan

Administered orally

Intervention Type DRUG

Placebo for Lasmiditan

Administered orally

Intervention Type DRUG

Placebo for Sumatriptan

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY573144

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes