Glendale, California 91206

  • Healthy Volunteers

Purpose:

The purpose of this study will be to evaluate the safety of a single dose of LY2484595 and to compare the amount of LY2484595 in the blood of healthy non-Asian subjects, Chinese subjects and first generation Japanese subjects after receiving a single oral dose of LY2484595 in a fasted state, after eating a low-fat meal and after eating a high-fat meal.


Criteria:

Inclusion Criteria: - Are overtly healthy males or females, as determined by medical history and physical examination. For Cohort B, a first-generation Japanese subject is defined as one who is Japanese and was born in Japan and whose parents and all grandparents are Japanese and were born in Japan. A first-generation Chinese subject is defined as one who is Chinese and was born in China (mainland or Taiwan) and whose parents and all grandparents are Chinese and were born in China - Female subjects are not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are at least age 45, have had cessation of menses for at least 1 year, and have not taken hormones or oral contraceptives (including estrogen or hormone replacement therapy) during the past 12 months - Are between the body mass index (BMI) of 18.5 and 29.0 kg/m^2, inclusive - Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator - Acceptable blood pressure (BP) and heart rate at both supine and standing positions as determined by the investigator (systolic BP less than or equal to 140 mm Hg, and diastolic BP less than or equal to 90 mm Hg). A single repeat BP measurement may be done at the discretion of the investigator - Have venous access sufficient to allow blood sampling - Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures - Have given written informed consent approved by Eli Lilly and Company (hereafter, Lilly) and the ethical review board (ERB) governing the site Exclusion Criteria: - Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device, or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study - Have known allergies to LY2484595 or related compounds - Are persons who have previously completed or withdrawn from this study - Have an abnormality in the 12-lead electrocardiogram (ECG) (including but not limited to a Bazett's corrected QT [QTcB] interval >450 msec for men and >470 msec for women) that, in the opinion of the investigator, increases the risks associated with participating in the study - Have a history within the last 2 years or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic 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 significant active neuropsychiatric disease - Regularly use known drugs of abuse and/or show positive findings on urinary drug screening - Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies - Show evidence of hepatitis C and/or positive hepatitis C antibody - Show evidence of hepatitis B and/or positive hepatitis B surface antigen - Are women with a positive pregnancy test or women who are lactating - Intend to use and actually use over-the-counter or prescription medication or dietary supplements within 14 days prior to dosing (acetaminophen is permissible on an as-needed basis, at less than 3 grams per day for less than 7 days) - Have donated blood of more than 500 mL within the last month - Have an average alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption for 48 hours prior and during the inpatient confinement at the Clinical Research Unit (CRU) (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits) - Use herbal supplements, grapefruit juice, grapefruits, Seville orange juice, Seville oranges, or starfruit within 7 days prior to study dosing - Smoke more than 10 cigarettes per day currently and are unwilling to abide by the CRU guidelines - Are unwilling to refrain from daily consumption of real licorice


NCT ID:

NCT01450098


Primary Contact:

Study Director
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)
Eli Lilly and Company

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone: 1-317-615-4559


Backup Contact:

N/A


Location Contact:

Glendale, California 91206
United States

Eli Lilly

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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