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Completed

NCT Number: NCT04972227

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Network, Long Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CY6463

Drug

oral tablets

Other names: IW-6463, Zagociguat

Placebo

Drug

oral tablets

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

Sponsors and collaborators

Lead sponsor

Tisento Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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