A Study of Lasmiditan in Healthy Elderly Participants
Condition: Healthy
Intervention: Lasmiditan; Placebo
Intervention description: Administered orally.; Administered orally.
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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 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.
    

Eligibility criteria:

        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.