A Study of Lasmiditan and Propranolol in Healthy Participants
Condition: Healthy
Intervention: Lasmiditan; Propranolol
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Propranolol; Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the effects on heart rate and blood pressure when a single dose of
      lasmiditan is administered with a daily dose of propranolol. This study will also measure how
      much lasmiditan gets into the bloodstream after taking lasmiditan alone and after taking it
      together with propranolol. The study will also look at how well both drugs are tolerated.
      Information about any side effects that may occur will be collected.

      This study will last approximately 45 days including screening. This study will require 13
      days/12 nights in a Clinical Research Unit (CRU) followed by 1 follow-up appointment
      approximately 7 days after the last dose. 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 to 35 kilograms per meter squared (kg/m²)
             inclusive, at the time of screening

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, propranolol, related compounds or any components
             of the formulation of lasmiditan or propranolol

          -  Have a history of, or electrocardiogram (ECG) findings of, clinically significant
             bradycardia, heart block, tachy or brady arrhythmias, sick sinus syndrome/sinoatrial
             block, or second or third-degree heart block, 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 an abnormal supine blood pressure, defined as systolic blood pressure less than
             (<) 95 or greater than (>) 140 millimeters of mercury (mmHg) or diastolic blood
             pressure <65 or >90 mmHg at screening

          -  Have a supine pulse rate of <50 or >90 beats per minute (bpm) at screening

          -  Have an estimated glomerular filtration rate (eGFR) of <60 milliliter per minute
             (mL/min) per 1.73 meter squared (m2)

          -  Show evidence of significant active neuropsychiatric disease (for example, manic
             depressive illness, schizophrenia, depression)

          -  Show a history of central nervous system (CNS) conditions such as strokes, transient
             ischaemic attacks, significant head trauma, CNS infections, migraines, brain surgery
             or any other neurological conditions that, in the opinion of the investigator,
             increases the risk of participating in the study

          -  Are women with a positive pregnancy test or women who are lactating