Status:
COMPLETED
A Study of Lasmiditan in Healthy Volunteers
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
Brief 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 participan...
Eligibility Criteria
Inclusion
- Are overtly healthy
- Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²)
Exclusion
- 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
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2021
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04749914
Start Date
February 15 2021
End Date
July 6 2021
Last Update
February 1 2024
Active Locations (1)
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1
Lilly Centre for Clinical Pharmacology
Singapore, Singapore, 138623