A Study of Lasmiditan in Healthy Elderly Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:65 - Any
Updated:6/3/2018
Start Date:January 25, 2018
End Date:April 13, 2018

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A Study to Investigate the Cardiovascular Effects of Lasmiditan in Healthy Elderly Subjects

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 get rid of it in healthy elderly participants. The tolerability of the
study drug will also be evaluated. Information about any side effects that may occur will
also be collected. This study will take about 11 days, not including screening. Screening is
required within 28 days prior to the start of the study.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
2
sites
Daytona Beach, Florida 32117
Principal Investigator: Hugh Coleman
Phone: 386-366-6446
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Daytona Beach, FL
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Madison, Wisconsin 53704
Principal Investigator: Nicholas Siebers
Phone: 608-443-1492
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Madison, WI
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