Status:
COMPLETED
A Study of Lasmiditan and Propranolol in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will assess the effects on heart rate and blood pressure when a single dose of lasmiditan is administered with a daily dose of propranolol. This study will also measure how much lasmiditan ...
Eligibility Criteria
Inclusion
- Healthy males or females, as determined by medical history and physical examination
- Have a body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²) inclusive, at the time of screening
Exclusion
- Have known allergies to lasmiditan, propranolol, related compounds or any components of the formulation of lasmiditan or propranolol
- Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias, sick sinus syndrome/sinoatrial block, or second or third-degree heart block, or have any other abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have an abnormal supine blood pressure, defined as systolic blood pressure less than (\<) 95 or greater than (\>) 140 millimeters of mercury (mmHg) or diastolic blood pressure \<65 or \>90 mmHg at screening
- Have a supine pulse rate of \<50 or \>90 beats per minute (bpm) at screening
- Have an estimated glomerular filtration rate (eGFR) of \<60 milliliter per minute (mL/min) per 1.73 meter squared (m2)
- Show evidence of significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
- Show a history of central nervous system (CNS) conditions such as strokes, transient ischaemic attacks, significant head trauma, CNS infections, migraines, brain surgery or any other neurological conditions that, in the opinion of the investigator, increases the risk of participating in the study
- Are women with a positive pregnancy test or women who are lactating
Key Trial Info
Start Date :
August 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2017
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03270644
Start Date
August 31 2017
End Date
November 22 2017
Last Update
December 16 2019
Active Locations (1)
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1
Covance Daytona Beach
Daytona Beach, Florida, United States, 32117