Healthy Volunteers Clinical Trial
Official title:
Biomarker Study: Impact of Single Doses of LY2979165 and LY2140023 on the Ketamine-Challenge Pharmacological MRI Assay in Healthy Male Subjects
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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