Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia
Schizophrenia
About this trial
This is an interventional other trial for Schizophrenia focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- 18 to 60 years of healthy and schizophrenic participants, inclusive, at the time of informed consent.
- Has acceptable clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis).
- Meets schizophrenia criteria as defined by the Diagnostic & Statistical Manual of Mental Disorders, 5th Edition (DSM-V).
- 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.
- Demonstrates Positive and Negative Syndrome Scale (PANSS) total score of less than equal to (<=) 85.
- Has a P50 ratio of > 0.5 at both screening assessments.
Exclusion Criteria:
- Has a history in the last year or currently receiving treatment with clozapine or olanzapine.
- Has taken any excluded medications, supplements or food products.
- 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.
- Has substance abuse or dependence within previous 12 months, unstable mood or anxiety disorder.
- Has a current diagnosis of a significant psychiatric illness other than schizophrenia per DSM-V and is in an acute phase/episode.
- Has clinically meaningful hearing loss per investigator's judgment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo + TAK-058 + Ondansetron
TAK-058 + Placebo + Ondansetron
Ondansetron + Placebo + TAK-058
Placebo + Ondansetron + TAK-058
TAK-058 + Ondansetron + Placebo
Ondansetron + TAK-058 + Placebo
TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 milligram (mg), solution, orally along with ondansetron placebo-matching capsule orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally along with TAK-058 placebo-matching solution, orally, on Day 1 of third intervention period (2 days).
TAK-058 150 mg, solution, orally along with ondansetron placebo-matching capsule orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of third intervention period (2 days).
Ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 mg, solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days).
TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 mg, solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days).
TAK-058 150 mg, solution, orally along with ondansetron placebo-matching capsule orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days).
Ondansetron 16 mg, capsule, orally along with TAK-058 placebo-matching solution, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 mg, solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days).