Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
NCT ID: NCT04972227
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2021-09-10
2022-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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CY6463
CY6463 once-daily (QD) for 14 days
CY6463
oral tablets
Placebo
placebo QD for 14 days
Placebo
oral tablets
Interventions
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CY6463
oral tablets
Placebo
oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
50 Years
ALL
No
Sponsors
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Tisento Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer Chickering
Role: STUDY_DIRECTOR
Cyclerion Therapeutics
Locations
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Collaborative Neuroscience Network
Long Beach, California, United States
Hassman Research Institute
Marlton, New Jersey, United States
Countries
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Other Identifiers
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C6463-103
Identifier Type: -
Identifier Source: org_study_id
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