A Study of Evacetrapib (LY2484595) in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/10/2018 |
| Start Date: | July 2013 |
| End Date: | November 2013 |
A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Tablet Solid Fractions
The purpose of this study is to measure and compare the amounts of the study drug evacetrapib
found in the blood after taking two different formulations. The study has 3 periods.
Participants will take each formulation by mouth at least once. A minimum of 14 days will
pass between study drug doses. The safety and tolerability of the study drug will also be
examined. Information about any side effects that may occur will also be collected. This
study will last approximately 6 weeks.
found in the blood after taking two different formulations. The study has 3 periods.
Participants will take each formulation by mouth at least once. A minimum of 14 days will
pass between study drug doses. The safety and tolerability of the study drug will also be
examined. Information about any side effects that may occur will also be collected. This
study will last approximately 6 weeks.
Inclusion Criteria:
- Male participants who agree to use a reliable method of birth control and not donate
sperm during the study and for 90 days after study completion
- Female participants who are not of child-bearing potential due to surgical
sterilization confirmed by medical history or menopause
- Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures
Exclusion Criteria:
- Are currently enrolled in or have completed or discontinued within the last 30 days
from a clinical trial involving an investigational product
- Have known allergies to evacetrapib, related compounds or any components of the
formulation, or history of significant allergic disease as determined by the
investigator
- Have a history or presence of cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, or neurological disorders
- Regularly use known drugs of abuse and/or show positive findings on urinary drug
screening
- Are women who are pregnant or lactating
- Have used or intend to use over-the-counter or prescription medications (including
vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during
the study
- Have donated blood of more than 500 milliliters (mL) within the last month
- Have an average weekly alcohol intake that exceeds 21 units per week (for males) and
14 units per week (for females) or are unwilling to stop alcohol consumption 48 hours
prior to each dose and while resident at the Clinical Research Unit (CRU)
- Currently smoke or use tobacco or nicotine products
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