Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia

Schizophrenia Clinical Trial

Official title: A Placebo-Controlled Study to Evaluate the Effect of a Single Dose of TAK-058 and Ondansetron on P50 Auditory Gating in Subjects With Stable Schizophrenia

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine whether improvement in P50 (a pharmacodynamic marker) in auditory sensory gating is demonstrated after administration of TAK-058 and ondansetron compared to placebo in participants with schizophrenia.

Clinical Trial Description

The drug being tested in this study is called TAK-058. TAK-058 is being tested to evaluate its effects on P50 auditory gating in people who have stable schizophrenia. This study will look at the effect of TAK-058 on P50 auditory gaiting of people with schizophrenia.

This study will be performed in a sequential manner progressing from an optimization (screening) phase in healthy volunteers, to screening of subjects with schizophrenia in part 1, to a 3 period crossover treatment phase in part 2. In the screening phase, 15 healthy volunteers will be enrolled to optimize the settings for the measurement of neurophysiological markers prior to any dosing in participants with schizophrenia. If optimization is not reached, the study will be terminated. In part 1 participants with schizophrenia will receive 2 P50 electroencephalography (EEG) sessions. A measurable deficit in auditory P50 gating S2/S1 ratio greater than (>) 0.5 will be established during this phase. The intraclass correlation coefficient (ICC) will be calculated for the P50 auditory gating S2/S1 ratios collected during the 2 sessions. If these P50 auditory gating S2/S1 ratio measurements are found to have at least a fair level of agreement within individuals (that is, ICC > 0.5), part 2 of the study will begin. 12 participants demonstrating P50 impairment in part 1, will be randomly assigned (by chance, like flipping a coin) to one of the six treatment crossover sequences —which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• Placebo + TAK-058 + Ondansetron

• TAK-058 + Placebo + Ondansetron

• Ondansetron + Placebo + TAK-058

• Placebo + Ondansetron + TAK-058

• TAK-058 + Ondansetron + Placebo

• Ondansetron + TAK-058 + Placebo

All participants will be asked to take one dose of capsule, followed 1 hour later by one dose of solution on Day 1 of each intervention period.

This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately118 days. Participants will make be confined to the clinic for 3 days (Day -1 through Day 2 of each period), a final visit for schizophrenic participants in Part 2 after receiving TAK-058, on Day 2 of Period 3 (no final visit for optimization phase healthy participants), and a telephonic follow up assessment 21 days after last dose of study drug. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Schizophrenia

• NCT number: NCT02614586
• Study type: Interventional
• Source: Takeda
• Status: Terminated
• Phase: Phase 1
• Start date: December 2015
• Completion date: June 2016