A Study of Two Dosage Forms of LY2886721 in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | February 2013 |
| End Date: | May 2013 |
| Contact: | There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
| Phone: | 1-317-615-4559 |
A Comparison Study of Capsule and Orally Disintegrating Tablet and to Determine the Effect of Food and Water on the Pharmacokinetics of LY2886721 in Healthy Subjects
The purpose of this study is to evaluate two different formulations of LY2886721. In
addition, this study will determine how much of study drug (LY2886721) gets into the blood
steam and how long the body takes to get rid of it after taking each formulation with or
without a meal. Information about any side effects that may occur will also be collected.
Each participant may be involved in the study for approximately 7 weeks.
This study requires 4 periods. In each period, participants will receive LY2886721 as a
tablet or capsule, with or without food and water. There is a 7 day washout between each
period.
Inclusion Criteria:
- Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2),
inclusive, at screening
- At least 4 participants who are greater than 55 years of age
- Male participants: Agree to use a reliable method of birth control and not donate
sperm during the study and for 3 months following the last dose of the
investigational product
- Female participants: Women not of child-bearing potential due to surgical
sterilization (at least 6 weeks after surgical bilateral oophorectomy, hysterectomy,
or both) confirmed by medical history, or postmenopausal females, as determined by
medical history and physical examination (spontaneous amenorrhea for 6 to 12 months
and a follicle stimulating hormone [FSH] level greater than 40 milli-international
units per milliliter [mIU/mL])
- Have venous access sufficient to allow for blood sampling as per the protocol
Exclusion Criteria:
- Are currently enrolled in, have completed, or discontinued within the last 30 days
from a clinical trial involving an investigational product; or are concurrently
enrolled in any other type of medical research judged not to be scientifically or
medically compatible with this study
- Have participated, within the last 30 days, in a clinical trial involving an
investigational product
- Have known allergies to LY2886721, related compounds, or any components of the
formulation
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Have a significantly abnormal blood pressure as determined by the investigator
- Have a history or current 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
- Regularly use known drugs of abuse and/or show positive findings on urinary drug
screening
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
HIV antibodies
- Show evidence of hepatitis B or C and/or positive hepatitis B or C antibody
- Have a history of, or current, significant ophthalmologic disease
- Show evidence of significant active neuropsychiatric disease or history of suicide
attempt
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