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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
are overtly healthy, right-handed, Caucasian (non-Hispanic White by self report) males, as determined by medical history and physical examination
agree to use an effective method of birth control during the study and for a period of 3 months after the final dose of study drug
if female partners are of child-bearing potential, agree to use 2 effective methods of birth control during the study and for a period of 3 months after the final dose of study drug
one (1) of these methods must be a male or female condom used in conjunction with spermicidal gel, foam, cream, film or suppository
the other method can be any of the following:
have a body mass index (BMI) of 18.0 to 30.0 kg/m^2, inclusive, and weigh 50.0 to 100.0 kg, at the time of screening
have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
have venous access sufficient to allow for blood sampling and administration of intravenous (IV) ketamine as per the protocol
are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
Exclusion criteria
Additional criteria for Part B only:
Primary purpose
Allocation
Interventional model
Masking
52 participants in 7 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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