A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT

NCT07061288 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CN012-0016
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 8

Brief Summary

A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia

Conditions

Schizophrenia

Keywords

KarXT; Long-acting injectable (LAI); Cobenfy

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events (AEs)

  Up to 3 weeks

• Number of participants with adverse events of special interest (AESIs)

  Up to 3 weeks

• Number of participants with serious adverse events (SAEs)

  Up to 3 weeks

Secondary Outcomes (11)

• Maximum concentration (Cmax)

  Up to 15 weeks

• Time to maximum concentration (Tmax)

  Up to 15 weeks

• Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

  Up to 15 weeks

• Area under the plasma concentration-time curve from time zero to infinity (AUC(INF))

  Up to 15 weeks

• Area under the plasma concentration-time curve from time zero to 672 hours (AUC(0-672))

  Up to 15 weeks

Study Arms (1)

Administration of KarXT

EXPERIMENTAL

Drug: KarXT

Interventions

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510

Administration of KarXT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (8)

Collaborative Neuroscience Research, LLC

Los Alamitos, California, 90720-3118, United States

RECRUITING

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

RECRUITING

Innovative Clinical Research, Inc.

Miami Lakes, Florida, 33016, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

RECRUITING

Uptown Research Institute

Chicago, Illinois, 60640, United States

RECRUITING

Hassman Research Institute Marlton Site

Marlton, New Jersey, 08053, United States

RECRUITING

Community Clinical Research

Austin, Texas, 78754, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): June 21, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (8)