A Study of LY3023414 Formulations and the Effect of Food
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/30/2016 |
| Start Date: | July 2016 |
| End Date: | September 2016 |
| Contact: | This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
| Phone: | 1-317-615-4559 |
Relative Bioavailability and the Effect of Food on the Bioavailability of LY3023414 in Healthy Subjects
The purpose of this study is to measure how much LY3023414 (a test formulation and a
reference formulation) gets into the blood stream and how long it takes the body to get rid
of it.
The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking
LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations
will be evaluated. Information about any side effects that may occur will be collected.
This study includes 3 periods. Participants will be admitted to the clinical research unit
(CRU) one day before dosing in each period. Total study duration is about 21 days, including
follow-up. Screening may occur up to 30 days before the first dose of study drug.
This study is for research purposes only and is not intended to treat any medical
conditions.
reference formulation) gets into the blood stream and how long it takes the body to get rid
of it.
The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking
LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations
will be evaluated. Information about any side effects that may occur will be collected.
This study includes 3 periods. Participants will be admitted to the clinical research unit
(CRU) one day before dosing in each period. Total study duration is about 21 days, including
follow-up. Screening may occur up to 30 days before the first dose of study drug.
This study is for research purposes only and is not intended to treat any medical
conditions.
Inclusion Criteria:
- Healthy surgically sterile or postmenopausal females and sterile males
- Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared
(kg/m²), inclusive at screening
Exclusion Criteria:
- Cannot be investigative site personnel directly affiliated with this study or their
immediate families. Immediate family is defined as a spouse, biological or legal
guardian, child, or sibling
- Cannot be Lilly employees
- Have known allergies to LY3023414, related compounds, or any components of the
formulation
- 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
We found this trial at
1
site
Daytona Beach, Florida 32117
Principal Investigator: Melanie Fein, MD
Phone: 386-366-6406
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