A Study of Lasmiditan in Healthy Volunteers
Condition: Healthy
Intervention: Lasmiditan; Dabigatran Etexilate; Rosuvastatin
Intervention description: Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Dabigatran; Rosuvastatin Calcium; Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Interaction Study

Summary:

      The main purpose of the study is to investigate the blood concentrations of dabigatran
      etexilate and rosuvastatin when taken alone compared to when taken together with lasmiditan
      in healthy participants. The safety and tolerability of dabigatran etexilate or rosuvastatin
      in combination with lasmiditan will also be evaluated in healthy participants. The study has
      two parts. Each part will last up to 17 days, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy

          -  Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²)

        Exclusion Criteria:

          -  have known allergies to lasmiditan, dabigatran, rosuvastatin-related compounds or any
             components of the formulation of lasmiditan, dabigatran, rosuvastatin, or a history of
             significant atopy

          -  have an abnormal blood pressure and/or pulse rate as determined by the investigator

          -  have clinically significant abnormalities on electrocardiogram (ECG) as determined by
             investigator

          -  have a history or presence of cardiovascular, respiratory, renal, gastrointestinal,
             endocrine, hematological, or neurological disorders capable of significantly altering
             the absorption, metabolism, or elimination of drugs; of constituting a risk when
             taking the study interventions; or of interfering with the interpretation of data.
             Appendectomy, splenectomy, and cholecystectomy are considered as acceptable

          -  have any medical conditions, medical history, or are taking any medications that are
             contraindicated in the dabigatran etexilate or rosuvastatin label

          -  are intending to use over-the-counter or prescription medication, including dietary
             supplements, traditional medicines, and herbal supplements, within 14 days prior to
             dosing and until study discharge (apart from occasional acetaminophen, hormonal
             contraception, or hormone replacement therapy)

          -  currently use or show evidence of substance abuse (including alcohol abuse) or
             dependence within the past 6 months based on history at screening

          -  Part 1 Only: have known bleeding disorder including prior personal or familial history
             of abnormal bleeding, hereditary or acquired coagulation or platelet disorder or
             abnormal coagulation test (prothrombin time/international normalized ratio [INR] or
             partial thromboplastin time/activated partial thromboplastin time greater than upper
             limit of normal [ULN]) result at screening

          -  Part 2 only: have c.34AA, c.421AA, or c.34GA/421CA genotypes of ABCG2 as determined
             through genotyping