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.
Participants must be healthy male and female (INOCBP) as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.
Participants must have BMI of 18.0 to 32.0 kg/m2.
Participants must not have organ dysfunction or any clinically significant deviation from normal in physical examination, VS, ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.
Participants must not have cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the LFT results.
Participants must not have any other significant acute or chronic medical illness, as assessed by the investigator.
Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
Parallel
KarXT
DrugSpecified dose on specified days
Midazolam
DrugSpecified dose on specified days
Fexofenadine
DrugSpecified dose on specified days
Digoxin
DrugSpecified dose on specified days
Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT
Part 1/1a: GMR of Area under the plasma concentration-time curve (AUC) of midazolam with and without KarXT
Part 2: GMR of Cmax of fexofenadine with and without KarXT
Part 2: GMR of AUC of fexofenadine with and without KarXT
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with physical examination abnormalities
Number of participants with vital sign abnormalities
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