A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
Specified dose on specified days
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States
RECRUITINGResearch Centers of America ( Hollywood )
Hollywood, Florida, United States
RECRUITINGInnovative Clinical Research, Inc.
Number of participants with adverse events (AEs)
Time frame: Up to 3 weeks
Number of participants with adverse events of special interest (AESIs)
Time frame: Up to 3 weeks
Number of participants with serious adverse events (SAEs)
Time frame: Up to 3 weeks
Maximum concentration (Cmax)
Time frame: Up to 15 weeks
Time to maximum concentration (Tmax)
Time frame: Up to 15 weeks
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to 15 weeks
Area under the plasma concentration-time curve from time zero to infinity (AUC(INF))
Time frame: Up to 15 weeks
Area under the plasma concentration-time curve from time zero to 672 hours (AUC(0-672))
Time frame: Up to 15 weeks
Apparent terminal phase half-life (T-HALF)
Time frame: Up to 15 weeks
Apparent total body clearance (CLT/F)
Time frame: Up to 15 weeks
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Up to 15 weeks
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Miami Lakes, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
RECRUITINGCenExel iResearch, LLC
Decatur, Georgia, United States
RECRUITINGUptown Research Institute
Chicago, Illinois, United States
RECRUITINGHassman Research Institute Marlton Site
Marlton, New Jersey, United States
RECRUITINGCommunity Clinical Research
Austin, Texas, United States
RECRUITINGNumber of participants with AEs
Time frame: Up to 3 weeks
Number of participants with AESIs
Time frame: Up to 3 weeks
Number of participants with SAEs
Time frame: Up to 3 weeks