Status:
COMPLETED
A Study of Lasmiditan in Healthy Elderly Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
The purposes of this study are to evaluate the effect of lasmiditan on blood pressure, as well as to look at the amount of study drug that gets into the blood stream and how long it takes the body to ...
Eligibility Criteria
Inclusion
- Are overtly healthy males or females, as determined through medical history and physical examination
- Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²), inclusive, at the time of screening.
Exclusion
- Have known allergies to lasmiditan, related compounds, or any components of the formulation.
- Are persons who have previously received lasmiditan.
- Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias, 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 significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. appendectomy, splenectomy, and cholecystectomy are considered as acceptable.
- Show a history of central nervous system (CNS) conditions such as strokes, transient ischemic attacks, significant head trauma, seizures, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increase the risk of participating in the study.
- Show evidence of active renal disease (e.g. diabetic renal disease, polycystic kidney disease) or estimated glomerular filtration rate \<60 milliliters per minute per 1.73 meter squared (mL/min/m²).
- Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03406260
Start Date
January 25 2018
End Date
April 13 2018
Last Update
December 2 2019
Active Locations (2)
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1
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
2
Covance Clinical Research Inc
Madison, Wisconsin, United States, 53704