A Study of Lasmiditan on the Heart in Healthy Participants
Condition: Healthy
Intervention: Lasmiditan; Lasmiditan; Placebo; Moxifloxacin
Intervention description: 100 mg administered orally (PO); 400 mg administered PO; Placebo administered for lasmiditan or moxifloxacin; 400 mg moxifloxacin administered PO
Intervention MeSH terms: Moxifloxacin; Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study was to determine how two doses of lasmiditan affected the heart in
      healthy participants. The study also evaluated how much lasmiditan got into the blood stream
      and how long it took the body to get rid of it. Information about side effects was collected.
      The study lasted a maximum of 46 days for each participant, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)

          -  In good physical and mental health as determined by the following:

               -  Complete medical history

               -  Complete physical examination

               -  Vital signs including blood pressure (supine and standing), heart rate (supine
                  and standing), respiratory rate, and temperature

               -  Standard 12-lead ECG (triplicate ECG), followed by a 24-hour Holter ECG for
                  arrhythmia monitoring

               -  Clinical laboratory tests

        Exclusion Criteria:

          -  Any of the following cardiac abnormalities on safety screening ECG:

               -  QTcF interval >430 milliseconds (ms) for males, >450 ms for females

               -  Unusual T wave morphology or flattened low voltage T waves

               -  PR interval >240 ms or <110 ms

               -  Second-degree or third-degree atrioventricular block

               -  ECG evidence of complete left or right bundle branch block

               -  Intraventricular conduction delay or QRS duration >110 ms

               -  Supine resting heart rate <45 beats per minute (bpm) or >90 bpm

               -  Pathological Q-waves

               -  Evidence of ventricular pre-excitation

          -  Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade
             de pointes, or structural heart disease

          -  Participants with a family history of Long QT syndrome

          -  History of allergic hypersensitivity to lasmiditan or any component of the
             formulations

          -  History or current evidence of abuse of any drug substance, licit or illicit,
             including alcohol; a positive urine screen for drugs of abuse

          -  Participants with a history of postural hypotension or fainting

          -  Participant is not able to understand and comply with study requirements, instructions
             and study restrictions