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CompletedNCT04972227Updated Aug 13, 2024

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

A Phase 1 interventional study of CY6463 and Placebo in Schizophrenia, sponsored by Tisento Therapeutics. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Tisento Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2022, 4 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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

02

Conditions studied

  • Schizophrenia

Browse trials for

Keywords

  • Cognitive Impairment Associated with Schizophrenia
  • CIAS
  • CY6463
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 48 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Tisento Therapeutics is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    CY6463

    CY6463 once-daily (QD) for 14 days

    Drug: CY6463

  • Placebo comparator
    Placebo

    placebo QD for 14 days

    Drug: Placebo

Interventions

  • DrugCY6463

    oral tablets

    Also known as: IW-6463, Zagociguat

  • DrugPlacebo

    oral tablets

06

What researchers measure

Primary outcomes

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

    Time frame: 28 (±4) days

Secondary outcomes

  1. Plasma concentrations of CY6463

    Time frame: up to Day 15

  2. Pharmacokinetic (PK) parameter: area under the concentration-time curve from time zero (predose) to 24 hours postdose (AUC0-24)

    Time frame: up to Day 15

  3. PK parameter: area under the concentration-time curve during a dosing interval (AUCtau)

    Time frame: up to Day 15

  4. PK parameter: average concentration during a dosing interval (Cavg)

    Time frame: up to Day 15

  5. PK parameter: maximum observed concentration (Cmax)

    Time frame: up to Day 15

  6. PK parameter: time to maximum observed concentration (Tmax)

    Time frame: up to Day 15

  7. PK parameter: minimum observed concentration (Cmin)

    Time frame: up to Day 15

  8. PK parameter: apparent systemic clearance (CL/F)

    Time frame: up to Day 15

  9. PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC)

    Time frame: up to Day 15

  10. PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax)

    Time frame: up to Day 15

07

Study locations

2 sites
  • Collaborative Neuroscience Network
    Long Beach, California 90806, United States
  • Hassman Research Institute
    Marlton, New Jersey 08053, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04972227
Lead sponsor
Tisento Therapeutics
Responsible party
Sponsor
First posted
Jul 22, 2021
Start date
Sep 10, 2021
Primary completion
Apr 18, 2022
Completion
Apr 18, 2022
Last update
Aug 13, 2024

Study contacts

Jennifer Chickering
study director · Cyclerion Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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