A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
- Registration Number
- NCT07061288
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the dose levels, safety, and drug levels of KarXT intramuscular injection in participants with Schizophrenia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Administration of KarXT KarXT -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Apparent terminal phase half-life (T-HALF) Up to 15 weeks Apparent total body clearance (CLT/F) Up to 15 weeks Apparent volume of distribution of terminal phase (Vz/F) Up to 15 weeks Number of participants with AEs Up to 3 weeks Number of participants with AESIs Up to 3 weeks Number of participants with SAEs Up to 3 weeks
Related Research Topics
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Trial Locations
- Locations (8)
Local Institution - 0001
🇺🇸Los Alamitos, California, United States
Local Institution - 0005
🇺🇸Hollywood, Florida, United States
Local Institution - 0004
🇺🇸Miami Lakes, Florida, United States
Local Institution - 0008
🇺🇸Atlanta, Georgia, United States
Local Institution - 0003
🇺🇸Decatur, Georgia, United States
Local Institution - 0002
🇺🇸Chicago, Illinois, United States
Local Institution - 0007
🇺🇸Marlton, New Jersey, United States
Local Institution - 0006
🇺🇸Austin, Texas, United States
Local Institution - 0001🇺🇸Los Alamitos, California, United StatesSite 0001Contact