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

Not Applicable

Recruiting

• Conditions: Schizophrenia
• Interventions: Drug: KarXT

• 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

Study Timeline

• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Study First Posted: 2025-07-11
• Status Verified: 2025-09
• Study Start: 2025-09-03
• Last Update Submitted: 2025-09-24
• Last Update Posted: 2025-09-29
• Primary Completion: 2027-06-21
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

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

Trial Locations

Locations (8)

Collaborative Neuroscience Research, LLC; 🇺🇸 Los Alamitos, California, 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

Hassman Research Institute Marlton Site; 🇺🇸 Marlton, New Jersey, United States

Local Institution - 0005; 🇺🇸 Hollywood, Florida, United States

Local Institution - 0002; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0006; 🇺🇸 Austin, Texas, United States