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

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Takeda
• Treatments: Ondansetron; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. 18 to 60 years of healthy and schizophrenic participants, inclusive, at the time of informed consent.

2. Has acceptable clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis).

3. Meets schizophrenia criteria as defined by the Diagnostic & Statistical Manual of Mental Disorders, 5th Edition (DSM-V).

4. Are on a stable dose of single second-generation antipsychotics (SGA) for at least 2 months prior to Screening as documented by medical history and assessed by site staff.

5. Demonstrates Positive and Negative Syndrome Scale (PANSS) total score of less than equal to (<=) 85.

6. Has a P50 ratio of > 0.5 at both screening assessments.

Exclusion Criteria:

1. Has a history in the last year or currently receiving treatment with clozapine or olanzapine.

2. Has taken any excluded medications, supplements or food products.

3. Has a history of gastrointestinal disease that would influence the absorption of study drug or have a significant medical history of any disease that would contraindicate the administration of TAK-058, ondansetron, or a similar compound.

4. Has substance abuse or dependence within previous 12 months, unstable mood or anxiety disorder.

5. Has a current diagnosis of a significant psychiatric illness other than schizophrenia per DSM-V and is in an acute phase/episode.

6. Has clinically meaningful hearing loss per investigator's judgment.