Overview

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

Status:
Recruiting

Trial end date:
2022-05-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Cyclerion Therapeutics

Criteria

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.