Status:
COMPLETED
A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 sumatripta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03310411
Start Date
October 17 2017
End Date
December 23 2017
Last Update
November 27 2019
Active Locations (1)
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1
Covance Daytona Beach
Daytona Beach, Florida, United States, 32117