The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of KarXT + KarX-EC capsules versus KarXT capsules in healthy adult and elderly participants of Japanese ethnicity and to assess the effect of multiple doses of omeprazole on the exposure of xanomeline and trospium administered as KarXT + KarX-EC capsules in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Cenexel ACT (Anaheim Clinical Trials)
Anaheim, California, United States
Number of participants with Adverse Events (AEs)
Part 1
Time frame: Up to 28 days post last dose
Number of participants with Serioues AEs (SAEs)
Part 1
Time frame: Up to 28 days post last dose
Number of participants with vital sign abnormalities
Part 1
Time frame: Up to 28 days post last dose
Body weight
Part 1
Time frame: Up to 28 days post last dose
Number of participants with 12-lead electrocardiogram abnormalities
Part 1
Time frame: Up to 28 days post last dose
Number of participants with physical examination abnormalities
Part 1
Time frame: Up to 28 days post last dose
Number of participants with clinical laboratory assessment abnormalities
Part 1
Time frame: Up to 28 days post last dose
Columbia-Suicide Severity Rating Scale (C-SSRS)
Part 1
Time frame: On Day 30
Maximum observed plasma concentration (Cmax)
Part 2
Time frame: Up to Day 29
Time of maximum observed plasma concentration (Tmax)
Part 2
Time frame: Up to Day 29
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Part 2
Time frame: Up to Day 29
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))
Part 2
Time frame: Up to Day 29
Apparent total body clearance (CLT/F)
Part 2
Time frame: Up to Day 29
Apparent volume of distribution (Vz/F)
Part 2
Time frame: Up to Day 29
Terminal elimination half-life (T-HALF)
Part 2
Time frame: Up to Day 29
Cmax
Part 1
Time frame: Up to Day 29
Tmax
Part 1
Time frame: Up to Day 29
AUC(0-24)
Part 1
Time frame: Up to Day 29
AUC(TAU)
Part 1
Time frame: Up to Day 29
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Part 1
Time frame: Up to Day 29
CLT/F
Part 1
Time frame: Up to Day 29
Vz/F
Part 1
Time frame: Up to Day 29
T-HALF
Part 1
Time frame: Up to Day 29
Number of participants with AEs
Part 2
Time frame: Up to 28 days post last dose
Number of participants with SAEs
Part 2
Time frame: Up to 28 days post last dose
Number of participants with vital sign abnormalities
Part 2
Time frame: Up to 28 days post last dose
Body weight
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Part 2
Time frame: Up to 28 days post last dose
Number of participants with 12-lead electrocardiogram abnormalities
Part 2
Time frame: Up to 28 days post last dose
Number of participants with physical examination abnormalities
Part 2
Time frame: Up to 28 days post last dose
Number of participants with clinical laboratory assessment abnormalities
Part 2
Time frame: Up to 28 days post last dose
C-SSRS
Part 2
Time frame: On Day 30