A Study of LY2623091 in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/8/2015 |
| Start Date: | November 2014 |
| End Date: | April 2015 |
| Contact: | This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
| Phone: | 1-317-615-4559 |
A Study to Determine the Effect of CYP3A Inhibition on the Pharmacokinetics of LY2623091 and the Effect of LY2623091 on the Pharmacokinetics of CYP3A Substrates in Healthy Subjects
The first purpose of this study is to evaluate the effect of itraconazole (and possibly
diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get
rid of it.
The second purpose of the study is to evaluate the effect of LY2623091 on the amount of
simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get
rid of it.
The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and
diltiazem or tadalafil will be evaluated.
There will be three groups of participants in this study. Results from Groups 1 and 2 will
be analyzed during the study to determine whether to enroll participants in Group 3 or 4.
The study is expected to last up to 40 days from the first dose to follow-up (inclusive).
Screening may occur up to 28 days prior to enrollment.
diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get
rid of it.
The second purpose of the study is to evaluate the effect of LY2623091 on the amount of
simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get
rid of it.
The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and
diltiazem or tadalafil will be evaluated.
There will be three groups of participants in this study. Results from Groups 1 and 2 will
be analyzed during the study to determine whether to enroll participants in Group 3 or 4.
The study is expected to last up to 40 days from the first dose to follow-up (inclusive).
Screening may occur up to 28 days prior to enrollment.
Inclusion Criteria:
- Healthy participants as determined by medical history, physical examination, clinical
laboratory tests, and electrocardiograms (ECGs).
- Have a body mass index (BMI) between 18 and 32.0 kilograms per square meter (kg/m^2)
inclusive, at screening
- Female participants must be of non-childbearing potential
Exclusion Criteria:
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
study
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