A Study of LY2940680 in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | September 2012 |
| End Date: | December 2012 |
| Contact: | This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
| Phone: | 1-317-615-4559 |
A Single Ascending Dose and Relative Bioavailability Study of LY2940680 in Healthy Subjects
This study involves 2 parts, Part A and Part B. The purpose of Part A is to evaluate the
safety and side effects of LY2940680 in healthy people. Part A will involve two groups of
participants, each taking up to two single doses of LY2940680 at different dose levels.
There is a minimum 14 day washout period between each of the participant's doses. The
purpose of Part B is to study how much of the study drug, in capsule or tablet form, gets
into the bloodstream and how long the body takes to get rid of it. In addition, the effect
of food and a proton pump inhibitor on LY2940680 will be studied. Part B will involve one
group of participants who will take four single doses of 100 mg LY2940680. There is a
minimum 7 day washout period between doses. Participants may only enroll in one part.
Screening is required within 28 days prior to the start of the study.
Inclusion Criteria:
- Healthy sterile males or surgically sterile females or postmenopausal females, as
determined by medical history and physical examination
- Body mass index of 18.5 to 32.0 kilograms per meter square (kg/m^2)
- Have clinical laboratory test results within normal reference range
- Have given written informed consent approved by Lilly and the ethical review board
(ERB) governing the site
- Prepared to eat an entire high fat breakfast
Exclusion Criteria:
- Are currently enrolled in, have completed or discontinued within the last 30 days
from, a clinical trial involving an investigational product
- Have known allergies to LY2940680, related compounds or any components of the
formulation, or known allergies to lansoprazole (Part B only)
- Have previously completed or withdrawn from this study or any other study
investigating LY2940680, and have previously received the investigational product.
Participants in Part A are not allowed to participate in Part B
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Have a history of 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 (cholecystectomy or appendectomy are allowed if surgery at
least 6 months prior to screening)
- 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 C and/or positive hepatitis C antibody
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- Have used or intend to use over-the-counter or prescription medication within 14 days
prior to dosing or during the study. Exception: participants may continue hormone
replacement therapy (HRT; estrogen)
- Use of herbal supplements, grapefruit juice, grapefruits, Seville orange juice,
Seville oranges, or Starfruit within 7 days prior to dosing or during the study
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