Cognitive Impairment Associated With Schizophrenia (CIAS)
Conditions
Keywords
Schizophrenia, Cognitive Dysfunction
Brief summary
This is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of 3 different dose regiments of KYN-5356 and placebo for 28 days. Participants will be randomized to one of 4 treatment groups: placebo, KYN-5356 low dose, KYN-5356 medium dose, KYN-5356 high dose. Participants will be admitted to the clinic on Day -3 and will remain in residence at the clinic for 32 days, from baseline through the treatment period. Participants will be administered investigational medicinal product on Days 1 through 28. Efficacy, safety, PK and exploratory PD assessments will be performed throughout the dosing period. Participants will be discharged on Day 29 after safety assessments are completed and return for a follow-up visit on Day 42. A subset of participants from selected sites will undergo electrophysiological assessments to evaluate the effect of KYN-5356 on neurophysiological measures of brain function.
Interventions
DRUGKYN-5356 low dose
oral tablet
OTHERPlacebo
Oral tablet
DRUGKYN-5356 Medium Dose
oral tablet
DRUGKYN-5356 High Dose
oral tablet
Sponsors
Kynexis B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Has an established primary psychiatric diagnosis of schizophrenia * Clinically stable and in the residual (nonacute) phase of their illness for at least 8 weeks before screening in the judgement of the investigator * Diagnosis of schizophrenia for at least 1 year before screening * Must be in ongoing maintenance antipsychotic monotherapy on a stable medication treatment regimen for ≥ 2 months before screening, including concomitant psychotropic medications. * Male or female, aged ≥18 and ≤55 years * Has a body mass index (BMI) between 18 and 40 kg/m2 Inclusive * Must exhibit capability to comply with all protocol procedures in the judgement of the investigator * Signed and dated written informed consent before screening in accordance with Good Clinical Practice.
Exclusion criteria
* Currently being treated with more than 1 antipsychotic at the time of screening, * A score of 2 or higher on any of the individual items of the Modified Simpson-Angus Scale (mSAS) at screening * Moderate to severe substance use disorder (other than nicotine or caffeine, but including alcohol) * Evidence of unstable medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS) | 28 days | Change from Baseline at Day 28 in the digital version of the Brief Assessment of Cognition for Schizophrenia (BAC App) composite T-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 28 days | Maximum concentration (Cmax) of KYN-5356 and relevant KYN-5356 metabolites on Day 1 and Day 28 |
| AUCtau | 28 Days | Area under the concentration-time curve from time 0 to tau (end of dosing interval) (AUCtau) of KYN-5356 and relevant KYN-5356 metabolites on Day1 and Day 28 |
| Tmax | 28 Days | Time to Cmax (Tmax) of KYN-5356 and relevant KYN-5356 metabolites on Day1 and Day 28 |
| Ctrough | 28 Days | Trough concentration (Ctrough) of KYN-5356 and relevant KYN-5356 metabolites on Days 1, 7, 14, 21, and 28 |
| Terminal half-life (t1/2) | 28 Days | Terminal half-life (t1/2) after the last dose on Day 28 for KYN-5356 and relevant KYN-5356 metabolites |
Countries
United States
Outcome results
None listed