Schizophrenia study: KarXT
Official title A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT
ClinicalTrials.gov ID: NCT07061288
What this study is testing
What is KarXT?
KarXT is an investigational injectable medicine being studied for schizophrenia.
Also referred to as BMS-986510.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe the drug is, how well people can tolerate it, and how it moves through the body.
- Who it's for
- Adults who have schizophrenia and are willing to try a new injectable medication.
- What's involved
- Participants will receive injections of KarXT and will have blood tests and medical check‑ups to monitor safety and drug levels.
- Time commitment
- The study will last a few weeks, with several clinic visits for injections and blood draws.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Participants must have a primary diagnosis of schizophrenia, as confirmed by psychiatric evaluation based on Diagnostic and Statistical Manual of...
- Participants must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 and a Clinical Global Impression - Severity (CGI-S) score ≤ 4...
- 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...
You likely can't join if
- 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...
- Participants must not be at risk for suicidal behavior.
- Female participants must not be pregnant or breastfeeding.
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Alamitos, California, United States
- Hollywood, Florida, United States
- Miami Lakes, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- Marlton, New Jersey, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Alamitos, California, United States; Hollywood, Florida, United States; Miami Lakes, Florida, United States; Atlanta, Georgia, United States; Decatur, Georgia, United States; Chicago, Illinois, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.