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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Collaborative Neuroscience Network
Long Beach, California, United States
Hassman Research Institute
Marlton, New Jersey, United States
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation
Time frame: 28 (±4) days
Plasma concentrations of CY6463
Time frame: up to Day 15
Pharmacokinetic (PK) parameter: area under the concentration-time curve from time zero (predose) to 24 hours postdose (AUC0-24)
Time frame: up to Day 15
PK parameter: area under the concentration-time curve during a dosing interval (AUCtau)
Time frame: up to Day 15
PK parameter: average concentration during a dosing interval (Cavg)
Time frame: up to Day 15
PK parameter: maximum observed concentration (Cmax)
Time frame: up to Day 15
PK parameter: time to maximum observed concentration (Tmax)
Time frame: up to Day 15
PK parameter: minimum observed concentration (Cmin)
Time frame: up to Day 15
PK parameter: apparent systemic clearance (CL/F)
Time frame: up to Day 15
PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC)
Time frame: up to Day 15
PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to Day 15