Schizophrenia
Conditions
Keywords
KarXT, Long-acting injectable (LAI), Cobenfy
Brief summary
A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia
Interventions
DRUGKarXT
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have a primary diagnosis of schizophrenia, as confirmed by psychiatric evaluation based on Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) criteria and Mini International Neuropsychiatric Interview (MINI) (version 7.0.2). * Participants must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 and a Clinical Global Impression - Severity (CGI-S) score ≤ 4 at both screening and baseline. * Participants must have a body mass index (BMI) between 18 and 40 kg/m². * Participants should be willing and able, as determined by the investigator, to discontinue all antipsychotic medications prior to the baseline visit and must be able to comply with all protocol requirements.
Exclusion criteria
* Participants must not have newly diagnosed schizophrenia or a first treated episode of schizophrenia. * Participants must not have any other DSM-5-TR disorder diagnosed within the past 12 months, such as major depressive disorder or bipolar disorder. * Participants must not have a history of alcohol or drug use disorder within the past 12 months or those with clinically significant disease or disorder that would jeopardize their safety or affect the validity of study results. * Participants must not be at risk for suicidal behavior. * Female participants must not be pregnant or breastfeeding. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 3 weeks |
| Number of participants with adverse events of special interest (AESIs) | Up to 3 weeks |
| Number of participants with serious adverse events (SAEs) | Up to 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) | Up to 15 weeks |
| Time to maximum concentration (Tmax) | Up to 15 weeks |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to 15 weeks |
| Area under the plasma concentration-time curve from time zero to infinity (AUC(INF)) | Up to 15 weeks |
| Area under the plasma concentration-time curve from time zero to 672 hours (AUC(0-672)) | Up to 15 weeks |
| Apparent terminal phase half-life (T-HALF) | Up to 15 weeks |
| Apparent total body clearance (CLT/F) | Up to 15 weeks |
| Apparent volume of distribution of terminal phase (Vz/F) | Up to 15 weeks |
| Number of participants with AEs | Up to 3 weeks |
| Number of participants with AESIs | Up to 3 weeks |
| Number of participants with SAEs | Up to 3 weeks |
Countries
United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed