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Ketamine Clinical Trials

Biomarker Study: Impact of Single Doses of LY2979165 and LY2140023 on the Ketamine-Challenge Pharmacological MRI Assay in Healthy Male Subjects

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Id: NCT01524237

Organisation Name: Eli Lilly and Company

Overal Status: Completed

Start Date: April 2012

Last Update: August 2, 2013

Lead Sponsor: Eli Lilly and Company

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.

  • Healthy Volunteers

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