This study is designed to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses and ratios of xanomeline and trospium chloride in an IR capsule (KarXT) and dual-burst release of xanomeline with immediate-release trospium chloride in adolescents with psychiatric disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Local Institution - 0005
Little Rock, Arkansas, United States
Local Institution - 0006
Orange, California, United States
Local Institution - 0007
Decatur, Georgia, United States
Local Institution - 0008
Overland Park, Kansas, United States
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 43
Number of participants with Serioues AEs (SAEs)
Time frame: Up to Day 43
Number of participants with AEs of Special Interest (AESIs)
Time frame: Up to Day 43
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 15
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Up to Day 15
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 15
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 15
Concentration at the end of a dosing interval (Ctau)
Time frame: Up to Day 15
Cmax accumulation index (AI_Cmax)
Ratio of maximum observed plasma concentration at steady-state on Day 5 to maximum observed plasma concentration after first dose
Time frame: Up to Day 15
AUC accumulation index (AI_AUC)
Ratio of area under the concentration-time curve in 1 dosing interval at steady-state on Day 5 to area under the concentration-time curve in 1 dosing interval after first dose
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Time frame: Up to Day 15
Ctau accumulation index (AI_Ctau)
Ratio of concentration at the end of the dosing interval at steady-state on Day 5 to maximum observed plasma concentration after first dose
Time frame: Up to Day 15
Average concentration within a dosing interval at steady-state (Css-avg)
Time frame: Up to Day 15
Apparent total body clearance (CLT/F)
Time frame: Up to Day 15
Effective elimination half-life during dosing interval (T-HALF(eff))
Time frame: Up to Day 15
T-HALFeff based on AUC observed (T-HALFeff_AUC)
Effective elimination half-life based on degree of area under the plasma concentration-time curve accumulation observed
Time frame: Up to Day 15