CompletedPhase 1

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

United States48 participantsStarted 2021-09-10

Plain-language 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

Who can participate

Age range18 Years – 50 Years

SexALL

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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

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

What they're measuring

Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation

Timeframe: 28 (±4) days

Trial details

NCT IDNCT04972227

SponsorTisento Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-18

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