The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Lenexa, Kansas, United States
Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT
Time frame: Up to approximately day 24
Part 1/1a: GMR of Area under the plasma concentration-time curve (AUC) of midazolam with and without KarXT
Time frame: Up to approximately day 24
Part 2: GMR of Cmax of fexofenadine with and without KarXT
Time frame: Up to approximately day 24
Part 2: GMR of AUC of fexofenadine with and without KarXT
Time frame: Up to approximately day 24
Part 3: GMR of Cmax of digoxin with and without KarXT
Time frame: Up to approximately day 24
Part 3: GMR of AUC of digoxin with and without KarXT
Time frame: Up to approximately day 24
Number of participants with adverse events (AEs)
Time frame: Up to approximately day 47
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately day 47
Number of participants with physical examination abnormalities
Time frame: Up to approximately day 24
Number of participants with vital sign abnormalities
Time frame: Up to approximately day 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Specified dose on specified days
Number of participants with 12-lead electrocardiogram abnormalities (ECGs)
Time frame: Up to approximately day 24
Number of participants with clinical laboratory assessment abnormalities
Time frame: Up to approximately day 24
Number of participants with suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately day 24
Number of participants with adverse event of special interest (AESIs)
Time frame: Up to approximately day 47