The purpose of this study is to evaluate the effects of lithium, valproic acid, and lamotrigine on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium, valproic acid, and lamotrigine in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Los Alamitos, California, United States
Maximum observed plasma concentration (Cmax)
Time frame: Up to day 54
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to day 54
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to day 54
Number of participants with adverse events (AEs)
Time frame: Up to 28 days post discontinuation of dosing
Number of participants with serious adverse events (SAEs)
Time frame: Up to 28 days post discontinuation of dosing
Number of participants with physical examination abnormalities
Time frame: Up to 2 days post discontinuation of dosing
Number of participants with vital sign abnormalities
Time frame: Up to 2 days post discontinuation of dosing
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time frame: Up to 2 days post discontinuation of dosing
Number of participants with clinical laboratory abnormalities
Time frame: Up to 2 days post discontinuation of dosing
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 2 days post discontinuation of dosing
Number of participants with AEs of Special Interest (AESIs)
Time frame: Up to 28 days post discontinuation of dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.