A Study of Lasmiditan in Participants With Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Lasmiditan
Intervention description: Administered orally
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Multi-center, open-label study with 2 study periods.
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure how much of the drug gets into the blood stream and
      how long it takes the body to get rid of it during an acute migraine attack and also during
      the time between acute migraine attacks.

      Information about any side effects that may occur will also be collected.

      This study includes two study periods. Each study period requires an overnight stay in the
      Clinical Research Unit (CRU) for at least one night (and up to three nights), followed by up
      to two outpatient appointments. This study will last approximately 5-6 weeks (not including
      screening).

      Follow-up is required four to seven days after last dose of investigational drug. Screening
      is required within 28 days prior to the start of the study.

      This study is for research purposes only and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females with history of migraine with or without aura, as defined by
             International Headache Society (IHS) International Classification of Headache
             Disorders (ICHD)-3 beta guidelines (1.1 and 1.2) (ICHD-3 beta, Cephalalgia 2013), for
             at least 1 year, based on medical history

          -  Have a body mass index (BMI) of 18.0 to 40.0 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 of lasmiditan

          -  Have participated, within the last 30 days, in a clinical study involving an
             investigational product. If the previous investigational product has a long half-life,
             5 half-lives or 30 days (whichever is longer) should have passed

          -  Have an abnormal blood pressure, defined as systolic blood pressure less than or equal
             to (≤) 90 or greater than (>) 155 millimeters of mercury (mmHg) or diastolic blood
             pressure ≤ to 50 or >95 mmHg

          -  Have clinically significant electrocardiogram (ECG) findings, including a QT interval
             corrected for heart rate using QT interval corrected for heart rate using Fridericia's
             formula (QTcF) value >450 milliseconds (ms) (males) or >470 ms (females), clinically
             significant bradycardia, cardiac block, or bradyarrhythmias

          -  Have a history of, show evidence of, or are undergoing treatment for significant
             active neuropsychiatric disease (for example, manic depressive illness, schizophrenia,
             major depressive disorder)

          -  Have a history of gastrointestinal surgery, or a history of or current irritable bowel
             syndrome, mal-absorptive disorders, or other gastrointestinal motility disorders.
             Appendectomy, splenectomy, and cholecystectomy are considered as acceptable

          -  Have used or intend to use any migraine prevention treatments (including, but not
             limited to, propranolol or topiramate) within 30 days prior to dosing and until the
             follow-up visit