A Study of LY2979165 and LY2140023 in Healthy Volunteers
Brief Summary
This study will be comprised of 2 parts, Part A and Part B, both in healthy male participants.
Part A of the study will investigate the safety of intravenous (IV) ketamine administration after single oral doses of LY2979165 (capsules) or LY2140023 (tablets). Part A will be completed before starting Part B.
Part B of this study will investigate whether different dose levels of LY2979165 or LY2140023, when administered before ketamine, result in changes to the images on a brain scan seen with ketamine alone. Brain imaging is currently used for a number of reasons including understanding where in the brain medicines have their effects. Ketamine is an anesthetic used in this study to activate particular regions of the brain.
The single oral doses of LY2979165 to be used in both parts of the study are 20 and 60 mg with matching dummy drug (placebo) for each dose.
The doses for LY2140023 are 10, 40, and 160 mg with matching placebo for each dose.
Screening is required within 28 days prior to the start of the study and follow up 7-14 days after the last dose of study drug. The study will last up to 8-weeks for an individual participant.
Condition or Disease
- Healthy Volunteers
Phase
Study Design
Study type: | Interventional |
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Status: | Completed |
Study results: | No Results Available |
Age: | 21 Years to 50 Years (Adult) |
Enrollment: | 52 () |
Funded by: | Industry |
Masking |
Clinical Trial Dates
Start date: | Apr 12, 2020 | |
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Primary Completion: | Jul 13, 2020 | |
Completion Date: | Jul 13, 2020 | |
Study First Posted: | Feb 01, 2012 | |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Aug 02, 2013 |
Sponsors / Collaborators
Eligibility Criteria
Sex: | Male |
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Minimum Age: | 21 |
Maximum Age: | 50 |
More Details
NCT Number: | NCT01524237 |
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Other IDs: | 13882|I4S-EW-HHCC |
Study URL: | https://ClinicalTrials.gov/show/NCT01524237 |