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.

Intervention / Treatment

  • Drug: LY2979165
  • Drug: LY2140023
  • Other: Placebo
  • Other: ketamine

Condition or Disease

  • Healthy Volunteers

Phase

Study Design

Study type: Interventional
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
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

Lead Sponsor: N/A
Responsible Party: N/A

Eligibility Criteria

Sex: Male
Minimum Age: 21
Maximum Age: 50

More Details

NCT Number: NCT01524237
Other IDs: 13882|I4S-EW-HHCC
Study URL: https://ClinicalTrials.gov/show/NCT01524237
Last updated: Feb 22, 2021