The purpose of this study is to evaluate the pharmacokinetics (PK) of xanomeline following administration of KarXT in CYP2D6 normal/extensive, intermediate, poor, and ultrarapid metabolizers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Specified dose on specified days
Anaheim Clinical Trials
Anaheim, California, United States
RECRUITINGICON - Lenexa
Lenexa, Kansas, United States
RECRUITINGICON Development Solutions
San Antonio, Texas, United States
RECRUITINGGeometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12))
Time frame: Up to Day 17
Number of participants with Adverse Events (AEs)
Time frame: Up to 28 days post last dose
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 28 days post last dose
Number of participants with physical examination abnormalities
Time frame: Up to 28 days post last dose
Number of participants with vital sign abnormalities
Time frame: Up to 28 days post last dose
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 28 days post last dose
Number of participants with clinical laboratory test abnormalities
Time frame: Up to 28 days post last dose
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 28 days post last dose
Number of participants with AEs of Special Interest (AESIs)
Time frame: Up to 28 days post last dose
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain the NCT# and Site #.
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.