A Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 10/10/2018 |
| Start Date: | April 2013 |
| End Date: | June 2013 |
Effect of Evacetrapib on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects
All study participants will receive both warfarin and a study drug called evacetrapib. The
main purpose of this study is to look at how much warfarin gets into the blood stream and how
long it takes the body to get rid of warfarin when given both with and without evacetrapib.
Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots
when given with evacetrapib by measuring the time it takes for blood to clot and comparing it
to an average of the international normalized ratio (INR). INR measures the time it takes for
blood to clot and compares it to an average.
The study will last approximately 5 weeks, not including screening.
main purpose of this study is to look at how much warfarin gets into the blood stream and how
long it takes the body to get rid of warfarin when given both with and without evacetrapib.
Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots
when given with evacetrapib by measuring the time it takes for blood to clot and comparing it
to an average of the international normalized ratio (INR). INR measures the time it takes for
blood to clot and compares it to an average.
The study will last approximately 5 weeks, not including screening.
Inclusion Criteria:
- Participants have given written informed consent approved by Lilly and the ethical
review board (ERB) governing the site
- A medical history and physical examination consistent with a being a healthy
individual
- Male participants will use a reliable method of birth control (as deemed by the
investigator) and not donate sperm during the study and for 3 months following the
last dose of the investigational product
- Female participants are not of child-bearing potential due to surgical sterilization
(at least 6 weeks after surgical hysterectomy, bilateral oophorectomy, or tubal
ligation) confirmed by medical history, or post-menopausal
- Have a body mass index (BMI) of 18 to 32 kilograms per square meter (kg/m^2)
- Participants are predicted to be cytochrome P450 2C9 (CYP2C9) extensive metabolizers
as determined by genotyping assessment
Exclusion Criteria:
- Have an abnormality in the 12-lead electrocardiogram (ECG) that increases the risks
associated with participating in the study
- Have an abnormal supine blood pressure
- Have a history or presence of cardiovascular, respiratory, hepatic, 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 medication; or of interfering with the
interpretation of data
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
HIV antibodies
- Show evidence of hepatitis C and/or positive hepatitis C antibody or evidence of
hepatitis B and/or positive hepatitis B surface antigen
- Women who are pregnant or are lactating
- Have used or intend to use over-the-counter or prescription medications (including
vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during
the study
- Have consumed grapefruit, cranberries, or grapefruit- or cranberry-containing products
within 7 days prior to the first dose of warfarin
- Have a history or presence of significant bleeding disorders that is, hematemesis,
melanena, severe or recurrent epistaxis, hemoptysis, clinically overt hematuria or
intracranial hemorrhage, gastrointestinal ulcers with hemorrhage
- Have a personal or family history of coagulation or bleeding disorders or reasonable
suspicion of vascular malformations, for example, cerebral hemorrhage, aneurysm or
premature stroke (cerebrovascular accident at <65 years of age)
- Have a history of major head trauma (with loss of consciousness) within the past year
or minor head trauma (without loss of consciousness) within the last 3 months prior to
screening or history of major surgery within 3 months of screening
- Have planned surgery within 14 days after the last day of dosing
- Have an international normalized ratio/prothrombin time (INR/PT), or activated partial
thromboplastin time (aPTT) above the normal reference range or abnormal Protein S
antigen and/or Protein C activity at screening
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