A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT (NCT07061288) | Clinical Trial Compass
RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT
United States116 participantsStarted 2025-09-03
Plain-language summary
A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily focused on safety and tolerability of an injectable form of KarXT, what does that mean for what's actually known about how well it works for schizophrenia at this stage?
2The trial is specifically testing an injectable version of KarXT — how does getting this medication by injection rather than by mouth change the risks, the schedule, or how closely I'd need to be monitored?
3The study is measuring serious adverse events as a key outcome, which tells me they're still learning about the safety profile — are there known side effects from the existing oral form of KarXT that I should be aware of before considering this?
4Given that this is an early-phase safety study, would it make more sense for me to discuss established treatments for schizophrenia first before thinking about enrolling in a trial like this?
5What would my participation actually look like day-to-day — how often would I need to come in for visits, and are there any lifestyle or scheduling demands that might be hard to manage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AEs)
Timeframe: Up to 3 weeks
2
Number of participants with adverse events of special interest (AESIs)
Timeframe: Up to 3 weeks
3
Number of participants with serious adverse events (SAEs)
Timeframe: Up to 3 weeks
Trial details
NCT IDNCT07061288
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-06-21
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com