RECRUITING

A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia

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Conditions

SchizophreniaKarXTLong-acting injectable (LAI)Cobenfy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the dose levels, safety, and drug levels of KarXT intramuscular injection in participants with Schizophrenia

Official Title

An Open-label, Phase 1, Single Ascending Dose-Finding Study to Characterize the Safety, Tolerability, and Pharmacokinetics of a Long Acting Injectable KarXT Formulation in Participants With Schizophrenia

Quick Facts

Study Start:2025-09-03
Study Completion:2027-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07061288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
8559073286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site#
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720-3118
United States
Local Institution - 0005
Hollywood, Florida, 33024
United States
Innovative Clinical Research, Inc.
Miami Lakes, Florida, 33016
United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
United States
CenExel iResearch, LLC
Decatur, Georgia, 30030
United States
Local Institution - 0002
Chicago, Illinois, 60640
United States
Hassman Research Institute Marlton Site
Marlton, New Jersey, 08053
United States
Local Institution - 0006
Austin, Texas, 78754
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-03
Study Completion Date2027-10-15

Study Record Updates

Study Start Date2025-09-03
Study Completion Date2027-10-15

Terms related to this study

Keywords Provided by Researchers

  • KarXT
  • Long-acting injectable (LAI)
  • Cobenfy

Additional Relevant MeSH Terms

  • Schizophrenia