RECRUITINGPhase 1INTERVENTIONAL
A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
An Open-label, Phase 1, Single Ascending Dose-Finding Study to Characterize the Safety, Tolerability, and Pharmacokinetics of a Long Acting Injectable KarXT Formulation in Participants With Schizophrenia
About This Trial
The purpose of this study is to evaluate the dose levels, safety, and drug levels of KarXT intramuscular injection in participants with Schizophrenia
Who May Be Eligible (Plain English)
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/Exclusion criteria apply.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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/Exclusion criteria apply.
Treatments Being Tested
DRUG
KarXT
Specified dose on specified days
Locations (8)
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Uptown Research Institute
Chicago, Illinois, United States
Hassman Research Institute Marlton Site
Marlton, New Jersey, United States
Community Clinical Research
Austin, Texas, United States