Study to Assess the Safety and Pharmacokinetics of CY6463... | NCT04972227

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

NCT04972227

Sponsor

Tisento Therapeutics

Status

Completed

Last Update Posted

Aug 13, 2024Actual

Enrollment

48Actual

Phase

Phase 1

Conditions

Schizophrenia

Interventions

CY6463
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2021Actual

Primary Completion Date

Apr 18, 2022Actual

Completion Date

Apr 18, 2022Actual

First Submitted Date

Jul 15, 2021

First Submission Date that Met QC Criteria

Jul 15, 2021

First Posted Date

Jul 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2024

Last Update Posted Date

Aug 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CY6463	Experimental	CY6463 once-daily (QD) for 14 days	Drug: CY6463
Placebo	Placebo Comparator	placebo QD for 14 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CY6463	Drug	oral tablets	CY6463	IW-6463 Zagociguat

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer Chickering	Cyclerion Therapeutics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Collaborative Neuroscience Network		Long Beach	California	90806	United States
Hassman Research Institute

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders