A Study of LY3009104 in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/30/2013 |
| Start Date: | February 2012 |
| End Date: | April 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 Placebo-Controlled, Single Dose, Dose Escalation (Part A) and a Placebo- and Positive-Controlled Study of the Effect on the Electrocardiographic QT Interval of a Single Dose (Part B) of LY3009104 in Healthy Subjects
This will be a 2-part, randomized, subject- and investigator-blind study in healthy males
and females.
Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that
yields drug exposures slightly exceeding typical exposures anticipated from repeated
administration of an efficacious dose to patients. The concentration of the drug in the
blood stream will be measured and information about any side effects that may occur will
also be collected.
Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of
the heart as measured by electrocardiogram (ECG) in relation to placebo following a single
oral dose.
Inclusion Criteria:
- Are overtly healthy males or females as determined by medical history and physical
examination. Are drug free, disease free, and no cardiac abnormalities.
- 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 a clinically normal screening electrocardiogram (ECG) with a measurable QT
interval as judged by the investigator, and which in Part B allows accurate
measurements of QT interval.
Exclusion Criteria:
- 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.
- Have an abnormality in the 12-lead ECG that, in the opinion of the investigator,
increases the risks associated with participating in the study or affects or
confounds the QTc analysis or have QTc greater than 450 msec.
- Regularly use known drugs of abuse and/or show positive findings on urinary drug
screening.
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