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

Tisento Therapeutics

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: CY6463

Study type: Interventional

Funder types: Industry

Identifiers

NCT04972227

C6463-103

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

CY6463

Experimental group

Description:

CY6463 once-daily (QD) for 14 days

Treatment:

Drug: CY6463

Placebo

Placebo Comparator group

Description:

placebo QD for 14 days

Treatment:

Drug: Placebo