Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the safety and tolerability of CY6463 when administered to participants with stable schizophrenia who are on a stable antipsychotic medication regimen

Official Title
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A Double-blinded, Randomized, Placebo-controlled, Multiple-ascending-dose Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: CY6463
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Provides written informed consent to participate in this study Body mass index is between 18 to 40 kg/m2 Fluent English speaker Diagnosed with schizophrenia at least 1 year ago Psychiatrically stable schizophrenia with no more than moderate symptomatology On a stable atypical antipsychotic regimen Agrees to use effective contraception throughout the study and for at least 3 months afterward Agrees to avoid using tobacco/nicotine and caffeine for several hours at a time Agrees to not participate in another study of a drug or device while in this study EXCLUSION CRITERIA: Was in another study of a drug in the past 2 months Fails a drug/alcohol screen, including amphetamines, barbiturates, cocaine, marijuana, methadone, methamphetamine, 3,4 methylenedioxymethamphetamine (MDMA), phencyclidine, or nonprescribed benzodiazepines or opiates Has had a recent heavy smoking habit (>40 cigarettes/2 packs/day) or recently had nicotine replacement therapy Has significant heart disease Has hemophilia or any other bleeding/platelet dysfunction condition Has hepatitis or HIV Additional inclusion and exclusion criteria apply, per protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Dose escalation study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CY6463<br>CY6463 once-daily (QD) for 14 days | Drug: CY6463<br>* oral tablets<br>|
| Placebo Comparator: Placebo<br>placebo QD for 14 days | Drug: Placebo<br>* oral tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation |  | 28 (±4) days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of CY6463 |  | up to Day 15 | 
| Pharmacokinetic (PK) parameter: area under the concentration-time curve from time zero (predose) to 24 hours postdose (AUC0-24) |  | up to Day 15 | 
| PK parameter: area under the concentration-time curve during a dosing interval (AUCtau) |  | up to Day 15 | 
| PK parameter: average concentration during a dosing interval (Cavg) |  | up to Day 15 | 
| PK parameter: maximum observed concentration (Cmax) |  | up to Day 15 | 
| PK parameter: time to maximum observed concentration (Tmax) |  | up to Day 15 | 
| PK parameter: minimum observed concentration (Cmin) |  | up to Day 15 | 
| PK parameter: apparent systemic clearance (CL/F) |  | up to Day 15 | 
| PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC) |  | up to Day 15 | 
| PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax) |  | up to Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Impairment Associated with Schizophrenia, CIAS, CY6463