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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: CY6463; Drug: Placebo

• Registration Number: NCT04972227
• Lead Sponsor: Tisento Therapeutics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-22
• Study Start: 2021-09-10
• Primary Completion: 2022-04-18
• Study Completion: 2022-04-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CY6463	CY6463	CY6463 once-daily (QD) for 14 days
Placebo	Placebo	placebo QD for 14 days

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation	28 (±4) days

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of CY6463	up to Day 15
PK parameter: maximum observed concentration (Cmax)	up to Day 15
PK parameter: time to maximum observed concentration (Tmax)	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
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

Trial Locations

Locations (2)

Collaborative Neuroscience Network; 🇺🇸 Long Beach, California, United States

Hassman Research Institute; 🇺🇸 Marlton, New Jersey, United States