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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04972227
Recruitment Status : Completed
First Posted : July 22, 2021
Last Update Posted : August 19, 2022
Sponsor:
Information provided by (Responsible Party):
Cyclerion Therapeutics

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: CY6463 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blinded, Randomized, Placebo-controlled, Multiple-ascending-dose Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
Actual Study Start Date : September 10, 2021
Actual Primary Completion Date : April 18, 2022
Actual Study Completion Date : April 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: CY6463
CY6463 once-daily (QD) for 14 days
Drug: CY6463
oral tablets

Placebo Comparator: Placebo
placebo QD for 14 days
Drug: Placebo
oral tablets




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04972227


Locations
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United States, California
Collaborative Neuroscience Network
Long Beach, California, United States, 90806
United States, New Jersey
Hassman Research Institute
Marlton, New Jersey, United States, 08053
Sponsors and Collaborators
Cyclerion Therapeutics
Investigators
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Study Director: Jennifer Chickering Cyclerion Therapeutics
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Responsible Party: Cyclerion Therapeutics
ClinicalTrials.gov Identifier: NCT04972227    
Other Study ID Numbers: C6463-103
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cyclerion Therapeutics:
Cognitive Impairment Associated with Schizophrenia
CIAS
CY6463
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders