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

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: CY6463; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA:

1. Provides written informed consent to participate in this study
2. Body mass index is between 18 to 40 kg/m2
3. Fluent English speaker
4. Diagnosed with schizophrenia at least 1 year ago
5. Psychiatrically stable schizophrenia with no more than moderate symptomatology
6. On a stable atypical antipsychotic regimen
7. Agrees to use effective contraception throughout the study and for at least 3 months afterward
8. Agrees to avoid using tobacco/nicotine and caffeine for several hours at a time
9. Agrees to not participate in another study of a drug or device while in this study

EXCLUSION CRITERIA:

1. Was in another study of a drug in the past 2 months
2. Fails a drug/alcohol screen, including amphetamines, barbiturates, cocaine, marijuana, methadone, methamphetamine, 3,4 methylenedioxymethamphetamine (MDMA), phencyclidine, or nonprescribed benzodiazepines or opiates
3. Has had a recent heavy smoking habit (>40 cigarettes/2 packs/day) or recently had nicotine replacement therapy
4. Has significant heart disease
5. Has hemophilia or any other bleeding/platelet dysfunction condition
6. Has hepatitis or HIV

Additional inclusion and exclusion criteria apply, per protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CY6463; CY6463 once-daily (QD) for 14 days	Drug: CY6463; oral tablets; Other Names: IW-6463; Zagociguat
Placebo Comparator: Placebo; placebo QD for 14 days	Drug: Placebo; oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tisento Therapeutics
• Investigators: Study Director: Jennifer Chickering, Cyclerion Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): April 18, 2022
• Study Completion (Actual): April 18, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive Impairment Associated with Schizophrenia; CIAS; CY6463
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: C6463-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No