A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
NCT ID: NCT07061288
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2025-09-03
2027-10-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Administration of KarXT
KarXT
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 8559073286
Email: [email protected]
First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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David Walling, Site 0001
Role: primary
Edwin Gomez, Site 0005
Role: primary
Rishi Kakar, Site 0004
Role: primary
Elyssa Barron, Site 0008
Role: primary
Kimball Johnson, Site 0003
Role: primary
John Sonnenberg, Site 0002
Role: primary
Elan Cohen, Site 0007
Role: primary
David Brown, Site 0006
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN012-0016
Identifier Type: -
Identifier Source: org_study_id