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

Schizophrenia Clinical Trial

Official title:

A Double-blinded, Randomized, Placebo-controlled, Multiple-ascending-dose Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04972227
• Other study ID #: C6463-103
• Status: Completed
• Phase: Phase 1
• Start date: September 10, 2021
• Est. completion date: April 18, 2022

Study information

• Verified date: September 2021
• Source: Tisento Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• CY6463
oral tablets
• Placebo
oral tablets

Locations

Country	Name	City	State
United States	Collaborative Neuroscience Network	Long Beach	California
United States	Hassman Research Institute	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Tisento Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation		28 (±4) days
Secondary	Plasma concentrations of CY6463		up to Day 15
Secondary	Pharmacokinetic (PK) parameter: area under the concentration-time curve from time zero (predose) to 24 hours postdose (AUC0-24)		up to Day 15
Secondary	PK parameter: area under the concentration-time curve during a dosing interval (AUCtau)		up to Day 15
Secondary	PK parameter: average concentration during a dosing interval (Cavg)		up to Day 15
Secondary	PK parameter: maximum observed concentration (Cmax)		up to Day 15
Secondary	PK parameter: time to maximum observed concentration (Tmax)		up to Day 15
Secondary	PK parameter: minimum observed concentration (Cmin)		up to Day 15
Secondary	PK parameter: apparent systemic clearance (CL/F)		up to Day 15
Secondary	PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC)		up to Day 15
Secondary	PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax)		up to Day 15