About this trial
The purpose of this study is to evaluate the pharmacokinetics (PK) of xanomeline following administration of KarXT in CYP2D6 normal/extensive, intermediate, poor, and ultrarapid metabolizers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant must be healthy male and female (INOCBP) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs (VS), and clinical laboratory determinations.
Participant must be a normal/extensive, intermediate, poor, or ultrarapid CYP2D6 metabolizer.
Participant must have body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
Disqualifiers
Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.
Other protocol-defined Inclusion/Exclusion criteria apply.
Trial design
Parallel
Treatments tested in this trial
Xanomeline/ Trospium Chloride
DrugSpecified dose on specified days
Treatment groups
Trial outcomes
Primary outcomes
Geometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12))
Secondary outcomes
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
Sponsors and contacts
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