The purpose of this study is to characterize the PK of xanomeline and trospium in breast milk and plasma in healthy lactating female participants, following multiple oral administration of KarXT in healthy lactating participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Specified dose on specified days
PPD | Las Vegas Clinical Research Unit
Las Vegas, Nevada, United States
RECRUITINGMaximum observed concentration (Cmax) of KarXT in Milk
Time frame: Up to Day 7
Time of maximum observed concentration (Tmax) of KarXT in Milk
Time frame: Up to Day 7
Area under the concentration-time curve from time zero to 12 hours post morning dose [AUC(0-12)] of KarXT in Milk
Time frame: Up to Day 7
Area under the concentration-time curve from time zero to 24 hours post morning dose [AUC(0-24)] of KarXT in Milk
Time frame: Up to Day 7
Average concentration (Cavg) of KarXT in Milk
Time frame: Up to Day 7
Amount of KarXT recovered in milk within 12 hours of dosing [AR(12)]
Time frame: Up to Day 7
Total amount of KarXT recovered in milk (AR)
Time frame: Up to Day 7
Milk-plasma ratio of KarXT (M/P)
Calculated as milk AUC(0-12)/plasma AUC(0-12)
Time frame: Up to Day 7
Cmax of KarXT in plasma
Time frame: Up to Day 7
Tmax of KarXT in plasma
Time frame: Up to Day 7
AUC (0-12) of KarXT in plasma
Time frame: Up to Day 7
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AUC (0-24) of KarXT in plasma
Time frame: Up to Day 7
Cavg of KarXT in plasma
Time frame: Up to Day 7
Estimated daily infant dosage of KarXT
Time frame: Up to Day 7
Relative infant dosage of KarXT
Time frame: Up to Day 7
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 34
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 34
Number of participants with physical examination abnormalities
Time frame: Up to Day 7
Number of participants with vital signs abnormalities
Time frame: Up to Day 7
Number of participants with 12-Lead electrocardiogram (ECG) abnormalities
Time frame: Up to Day 7
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 7
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 7
Number of participants with Adverse Events of Special Interest (AESIs)
Time frame: Up to Day 34