Schizophrenia
Conditions
Keywords
Cognitive Impairment Associated with Schizophrenia, CIAS, CY6463
Brief 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
Interventions
DRUGCY6463
oral tablets
DRUGPlacebo
oral tablets
Sponsors
Tisento Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Dose escalation study
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation | 28 (±4) days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) parameter: area under the concentration-time curve from time zero (predose) to 24 hours postdose (AUC0-24) | up to Day 15 |
| PK parameter: area under the concentration-time curve during a dosing interval (AUCtau) | up to Day 15 |
| PK parameter: average concentration during a dosing interval (Cavg) | up to Day 15 |
| PK parameter: maximum observed concentration (Cmax) | up to Day 15 |
| Plasma concentrations of CY6463 | up to Day 15 |
| PK parameter: minimum observed concentration (Cmin) | up to Day 15 |
| PK parameter: apparent systemic clearance (CL/F) | up to Day 15 |
| PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC) | up to Day 15 |
| PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax) | up to Day 15 |
| PK parameter: time to maximum observed concentration (Tmax) | up to Day 15 |
Countries
United States
Outcome results
None listed