RecruitingPhase 1NCT07204418
A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants
A Phase 1, 4-part, Open-label Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Enrollment
56 participants
Start Date
Oct 13, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria3
- 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 Criteria1
- 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.
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Interventions
DRUGXanomeline/ Trospium Chloride
Specified dose on specified days
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07204418
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