Food-Effect Study in Healthy Participants
Condition: Healthy
Intervention: Lasmiditan
Intervention description: 2 discrete doses separated by 6 days.
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of
      lasmiditan in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18-50 years.

          -  Able and willing to give written informed consent.

          -  Females of child bearing potential must be using or willing to use a medically
             acceptable method (as defined by the Investigator) of birth control.

          -  Body mass index (BMI) within 19 and 29.9 kilograms per meter squared (kg/m²).

          -  No clinically significant abnormalities (as determined by the Principal Investigator)
             in hematology, blood chemistry and urinalysis lab tests at screening.

          -  No history of alcohol or drug abuse within the past year. Negative urinary drugs of
             abuse and alcohol screen determined within 21 days of the start of the study and at
             check-in Day -1.

          -  Must be able to understand the requirements of the study and must be willing to comply
             with the requirements of the study.

        Exclusion Criteria:

          -  Any medical condition or clinical laboratory test which in the judgment of the
             Investigator makes the participant unsuitable for the study.

          -  Pregnant or breast-feeding women.

          -  Use of any prescription within 14 days prior to dosing (except hormonal
             contraceptives) or over the-counter medications, including vitamins and herbal or
             dietary supplements within 7 days prior to dosing unless approved by the Investigator
             and Medical Monitor.

          -  History within the previous 3 years or current evidence of abuse of any drug,
             prescription or illicit, or alcohol; a positive urine screen for drugs of abuse or
             alcohol.

          -  History of orthostatic hypotension with or without syncope.

          -  At imminent risk of suicide (positive response to question 4 or 5 on the
             Columbia-Suicide Severity Rating Scale [C-SSRS]) or had a suicide attempt within 6
             months prior to screening.

          -  Participation in any clinical trial of an experimental drug or device in the previous
             30 days.

          -  Positive Hepatitis C antibody, Hepatitis B surface antigen, or positive human
             immunodeficiency virus (HIV) antibody.

          -  Donated plasma in the 7 days or blood in the 3 months preceding study drug
             administration.

          -  Inability to communicate well with the Investigator and study staff (i.e., language
             problem, poor mental development or impaired cerebral function).

          -  Inability to fast or consume the food provided in the study.

          -  Relatives of, or staff directly reporting to, the Investigator.