SchizophreniaPhase 1NCT04972227
Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
A Phase 1 study testing CY6463 in people with Schizophrenia, run by Tisento Therapeutics at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- CY6463
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2021to 18 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Collaborative Neuroscience Network
Long Beach, California, 90806
Hassman Research Institute
Marlton, New Jersey, 08053
About this study
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
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
- Being tested
- CY6463, Placebo
- Keywords
- Cognitive Impairment Associated with Schizophrenia, CIAS, CY6463
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CY6463Drug
Also called IW-6463, Zagociguat
oral tablets
PlaceboDrug
oral tablets
| Study group | Role | What they receive |
|---|---|---|
| CY6463 | Experimental | CY6463 once-daily (QD) for 14 days Receives: Drug: CY6463 |
| Placebo | Placebo comparator | placebo QD for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation
Measured: 28 (±4) days
Secondary outcomes (10)
Plasma concentrations of CY6463
Measured: up to Day 15
Pharmacokinetic (PK) parameter: area under the concentration-time curve from time zero (predose) to 24 hours postdose (AUC0-24)
Measured: up to Day 15
PK parameter: area under the concentration-time curve during a dosing interval (AUCtau)
Measured: up to Day 15
PK parameter: average concentration during a dosing interval (Cavg)
Measured: up to Day 15
PK parameter: maximum observed concentration (Cmax)
Measured: up to Day 15
PK parameter: time to maximum observed concentration (Tmax)
Measured: up to Day 15
PK parameter: minimum observed concentration (Cmin)
Measured: up to Day 15
PK parameter: apparent systemic clearance (CL/F)
Measured: up to Day 15
PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC)
Measured: up to Day 15
PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax)
Measured: up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start10 Sep 2021
- Primary completion18 Apr 2022
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tisento Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Chickering, Study director, Cyclerion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972227
- Sponsor's protocol ID
- C6463-103
- Status last verified
- Aug 2024
- First submitted
- 15 Jul 2021
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04972227
- Acronym / sponsor ID
- C6463-103
- Conditions
- Schizophrenia
- Keywords
- Cognitive Impairment Associated with Schizophrenia, CIAS, CY6463
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tisento TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| CY6463 | Experimental | Drug: CY6463CY6463 once-daily (QD) for 14 days |
| Placebo | Placebo comparator | Drug: Placeboplacebo QD for 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CY6463Also: IW-6463, Zagociguatoral tablets | Drug | CY6463 |
| Placebooral tablets | Drug | Placebo |
Primary outcome
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
10 secondary outcomes
Plasma concentrations of CY6463
Time frame: up to Day 15
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
PK parameter: area under the concentration-time curve during a dosing interval (AUCtau)
Time frame: up to Day 15
PK parameter: average concentration during a dosing interval (Cavg)
Time frame: up to Day 15
PK parameter: maximum observed concentration (Cmax)
Time frame: up to Day 15
PK parameter: time to maximum observed concentration (Tmax)
Time frame: up to Day 15
PK parameter: minimum observed concentration (Cmin)
Time frame: up to Day 15
PK parameter: apparent systemic clearance (CL/F)
Time frame: up to Day 15
PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC)
Time frame: up to Day 15
PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax)
Time frame: up to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Chickering study director
Cyclerion Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CY6463 in people with Schizophrenia, run by Tisento Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.