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

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT04972227

Run by

Tisento Therapeutics

People needed

48

Starts

2021-09-10

Expected to finish

2022-04-18

Last updated by the study team

2024-08-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Collaborative Neuroscience Network — Long Beach, California, United States
• Hassman Research Institute — Marlton, New Jersey, United States

Full record on ClinicalTrials.gov

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