A Study of Lasmiditan in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, 2-Part Study to Investigate the Effect of Lasmiditan on the Pharmacokinetics of Dabigatran and Rosuvastatin in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lasmiditan
* Drug: Dabigatran Etexilate
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lasmiditan + Dabigatran (Part 1)<br>Participants will receive single doses of dabigatran followed by combination of lasmiditan along with dabigatran etexilate administered orally. | Drug: Lasmiditan<br>* Administered orally.<br>* Other names: LY573144;Drug: Dabigatran Etexilate<br>* Administered orally.<br>|
| Experimental: Lasmiditan + Rosuvastatin (Part 2)<br>Participants will receive single doses of rosuvastatin followed by combination of lasmiditan along with rosuvastatin administered orally. | Drug: Lasmiditan<br>* Administered orally.<br>* Other names: LY573144;Drug: Rosuvastatin<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran to Assess P-glycoprotein (P-gp) Activity. | PK: Cmax of Dabigatran | Predose up to 72 hour postdose | 
| PK: Cmax of Rosuvastatin to Assess Breast Cancer Resistance Protein (BCRP) Activity. | PK: Cmax of Rosuvastatin | Predose up to 72 hour postdose | 
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] ) of Dabigatran to Assess P-gp Activity. | PK: AUC[0-∞] of Dabigatran | Predose up to 72 hour postdose | 
| PK: AUC[0-∞] of Rosuvastatin to Assess BCRP Activity. | PK: AUC[0-∞] of Rosuvastatin | Predose up to 72 hour postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Interaction Study