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A Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Evacetrapib (Drug); Warfarin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Summary

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.

Clinical Details

Official title: Effect of Evacetrapib on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of S-Warfarin

Pharmacokinetics (PK): Maximum Concentration (Cmax) of S-Warfarin

Secondary outcome:

Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of R-Warfarin

Pharmacokinetics (PK): Maximum Concentration (Cmax) of R-Warfarin

Pharmacodynamics (PD): Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin

Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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 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 less than 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

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Madison, Wisconsin 53704, United States
Additional Information

Starting date: April 2013
Last updated: June 27, 2013

Page last updated: August 23, 2015

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