A Study of Multiple Doses of Lasmiditan in Healthy Participants
Condition: Healthy
Intervention: Probe Drug Cocktail; Lasmiditan; Placebo
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood
      stream and how long it takes the body to get rid of it.

      When drugs are taken together, one or all of the drugs used in combination may be affected.
      This study will also evaluate the concentrations in the blood of a probe drug cocktail taken
      alone and in combination with lasmiditan. Information about any side effects that may occur
      will also be collected.

      The study has two parts. Participants will only enroll in one part. This study will last
      about 25 days for group 1 and 22 days for group 2, not including screening. 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:

          -  Healthy males or females, as determined by 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 participated, within the last 30 days, in a clinical study involving an
             Investigational Product (IP)

          -  Have previously completed or withdrawn from this study or any other study
             investigating Lasmiditan, and have previously received Lasmiditan

          -  Have clinically significant abnormality in the 12-lead ECG, including corrected QT
             interval (QTc) with Fridericia's correction (QTcF) greater than (>) 450 milliseconds
             (ms) for men or >470 ms for women or any abnormality that in the opinion of the
             investigator increases the risk of participating in the study (not limited to
             significant bradycardia or heart block)

          -  History of, show evidence of, or are undergoing treatment for significant active
             neuropsychiatric disease (for example, manic depressive illness, schizophrenia,
             depression), have a recent history of a suicide attempt (30 days within screening
             visit and any time between screening visit and baseline); or are clinically judged by
             the investigator to be at risk for suicide

          -  History of hypoglycemia

          -  Known history of glucose-6-phosphate dehydrogenase deficiency

          -  Are taking a concomitant medication or a dietary substance that affects cytochrome
             P450 (CYP)1A2, CYP2C9, and/or CYP3A isotypes within 14 days of screening