Clinical trial: A Study of Lasmiditan in Healthy Volunteers (NCT04749914)

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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years.

Patient description (patient's own words): I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL.

Does the patient match the trial criteria? Contradiction