Ketamine-Induced Brain Activity Changes Clinical Trial
Official title:
A Randomized, Investigator and Subject-Blind, Placebo-Controlled, Single-Dose, 3-Period, Incomplete Block Cross-Over Study to Evaluate the Effects of Single Oral Administration of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults
The purpose of this study is to determine whether ketamine-induced brain activity changes are modulated by TAK-063 administration using neuroimaging battery tests.
The drug being tested in this study is called TAK-063. This study will look at brain
activity changes and treatment of psychotic-like symptoms induced by Ketamine, in people who
take TAK-063.
The study will enroll approximately 27 patients. Participants will be randomly assigned to
one of treatment sequences—which will remain undisclosed to the patient during the study
(unless there is an urgent medical need). Participants will receive the following study
medications by the end of the study:
- Ketamine intravenous infusion (IV) AND
- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
no active ingredient AND
- Two doses of TAK-063 at one of three dose levels All participants will be asked to take
3 tablets and will receive a ketamine IV on the first day of 3 separate study periods.
Participants will then be assessed for brain activity changes and other symptoms. This
single-centre trial will be conducted in the United States. The overall time to
participate in this study is up to 7 weeks. Participants will make 6 visits to the
clinic.
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science