Clinical trial NCT04972227: Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Cognitive Impairment Associated with Schizophrenia
CIAS
CY6463
Lead sponsor: Tisento Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation study
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation
timeFrame: 28 (±4) days
Secondary outcomes:
measure: Plasma concentrations of CY6463
timeFrame: up to Day 15
measure: Pharmacokinetic (PK) parameter: area under the concentration-time curve from time zero (predose) to 24 hours postdose (AUC0-24)
timeFrame: up to Day 15
measure: PK parameter: area under the concentration-time curve during a dosing interval (AUCtau)
timeFrame: up to Day 15
measure: PK parameter: average concentration during a dosing interval (Cavg)
timeFrame: up to Day 15
measure: PK parameter: maximum observed concentration (Cmax)
timeFrame: up to Day 15
measure: PK parameter: time to maximum observed concentration (Tmax)
timeFrame: up to Day 15
measure: PK parameter: minimum observed concentration (Cmin)
timeFrame: up to Day 15
measure: PK parameter: apparent systemic clearance (CL/F)
timeFrame: up to Day 15
measure: PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC)
timeFrame: up to Day 15
measure: PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax)
timeFrame: up to Day 15
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
Study officials:
affiliation: Cyclerion Therapeutics
name: Jennifer Chickering
role: STUDY_DIRECTOR
References: