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

NCT04972227 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: C6463-103
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Schizophrenia

Keywords

Cognitive Impairment Associated with Schizophrenia; CIAS; CY6463

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation

  28 (±4) days

Secondary Outcomes (10)

• 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

Study Arms (2)

CY6463

EXPERIMENTAL

CY6463 once-daily (QD) for 14 days

Drug: CY6463

Placebo

PLACEBO COMPARATOR

placebo QD for 14 days

Drug: Placebo

Interventions

CY6463 DRUG

oral tablets

Also known as: IW-6463, Zagociguat

CY6463

Placebo DRUG

oral tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tisento Therapeutics: lead

Study Sites (2)

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jennifer Chickering

  Cyclerion Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation study

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 22, 2021
• Study Start: September 10, 2021
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)