Tests an injectable form of KarXT in people with schizophrenia
Checks safety and how the body processes an injectable KarXT in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT
Key facts
- Where
- Atlanta, Austin, Chicago, Decatur, Hollywood, Los Alamitos, Marlton, and Miami Lakes, United StatesSee the 8 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07061288, who can take part
Where in United States
- Atlanta Center for Medical ResearchAtlanta, United StatesTaking people
- Community Clinical ResearchAustin, United StatesTaking people
- Uptown Research InstituteChicago, United StatesTaking people
- CenExel iResearch, LLCDecatur, United StatesTaking people
- Research Centers of America (Hollywood)Hollywood, United StatesTaking people
- Collaborative Neuroscience Research, LLCLos Alamitos, United StatesTaking people
- Hassman Research Institute Marlton SiteMarlton, United StatesTaking people
- Innovative Clinical Research, Inc.Miami Lakes, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07061288
- Record updated
- 2 September 2026
- Original description
A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophreniaRead full original descriptionShow less
An Open-label, Phase 1, Dose-Finding Study to Characterize the Safety, Tolerability, and Pharmacokinetics of a Long-Acting Injectable KarXT Formulation in Participants With Schizophrenia
A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia
Inclusion: 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: 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 have newly diagnosed schizophrenia or a first treated episode of schizophrenia; Participants must not be at risk for suicidal behavior; Female participants must not be pregnant or breastfeeding; Other protocol-defined Inclusion/Exclusion criteria apply.