NCT07204418PHASE1RecruitingAccepts Healthy Volunteers
A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Start Date
10/13/2025
Completion Date
12/3/2026
Summary
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
Age Range: 18 years to 65 years
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Interventions
DRUG
Xanomeline/ Trospium Chloride
Conditions
Healthy Volunteers
Locations
Anaheim Clinical Trials
Anaheim, California 92801
United States
ICON - Lenexa
Lenexa, Kansas 66219-9746
United States
ICON Development Solutions
San Antonio, Texas 78209
United States