A Study to Evaluate Central Nervous System (CNS) Pharmacodynamic Activity of TAK-653 in Healthy Participants Using Transcranial Magnetic Stimulation (TMS)

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
The drug being tested in this study is called TAK‐653. This study is designed to evaluate the central pharmacodynamic activity of TAK‐653 using TMS. The study will enroll approximately 24 participants to yield 22 participants that complete treatment periods 1, 2 and 3. Participants will be randomly assigned to 1 of the 6 sequences to receive TAK‐653 0.5 mg low dose or TAK‐653 6 mg high dose or Placebo in double‐blind treatment periods 1, 2 and 3, followed by Ketamine 0.5 mg/kg in open‐label Treatment period 4. All participants will receive one dose of TAK‐653 (0.5 or 6 mg), or Placebo or Ketamine on Day 1 of each treatment period. This single center trial will be conducted in the Netherlands. The overall time to participate in this study is 15 weeks. Participants will make 5 visits to the clinic. A washout period of minimum 10 days will be maintained between the doses in treatment periods 1 to 3. Follow‐up phone call will be made on Day 14.
Epistemonikos ID: f640c573c3a47d460b4abb344d098ea87f5b766f
First added on: May 21, 2024