A Study of LY2484595 in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 10/5/2018 |
Start Date: | October 2011 |
End Date: | December 2011 |
Single Dose LY2484595 Tablet Formulations to Determine the Impact of Dose Level, Food, and Ethnicity on the Pharmacokinetics in Healthy Subjects
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.
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.
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
- Have a body mass index (BMI) of 18.5 to 29.0 kilograms per meter squared (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
- Have an 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
millimeters of mercury [mmHg], and diastolic BP less than or equal to 90 mmHg). 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 milliseconds (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 milliliters (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 ounces [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
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