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

Not Applicable
Not yet recruiting
Conditions
Schizophrenia
Interventions
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Administration of KarXTKarXT-
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 AEsUp to 3 weeks
Number of participants with AESIsUp to 3 weeks
Number of participants with SAEsUp to 3 weeks

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 States
Site 0001
Contact

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