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

Phase 1 Completed 24 enrolled Neurocrine Biosciences Takeda · collab

RandomizedCrossoverDouble-blindOther

Summary

The primary purpose of this study is to determine whether TAK-653, in comparison to placebo, increases CNS excitability, assessed with TMS-evoked motor-evoked potential (MEP) in healthy participants.

Timeline

Start: 2019-02-11
Primary completion: 2019-05-15
Completion: 2019-06-18

Publications

Dijkstra F, O'Donnell P, Klaassen E, Buhl D, Asgharnejad M, Rosen L, Zuiker R, van Gerven J, Jacobs G. Central nervous system effects of TAK-653, an investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole receptor (AMPAR) positive allosteric modulator in healthy volunteers. Transl Psychiatry. 2022 Sep 24;12(1):408. doi: 10.1038/s41398-022-02148-w.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketamine	Small molecule	0.5 mg/kg	Intravenous
Subject	OSAVAMPATOR	Small molecule	0.5 mg	Oral
Subject	OSAVAMPATOR	Small molecule	6 mg	Oral

Indications

No indication recorded.