Status:
RECRUITING
A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants
Lead Sponsor:
Karuna Therapeutics
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 3 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT07204418
Start Date
October 13 2025
End Date
December 3 2026
Last Update
November 14 2025
Active Locations (3)
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1
Anaheim Clinical Trials
Anaheim, California, United States, 92801
2
ICON - Lenexa
Lenexa, Kansas, United States, 66219-9746
3
ICON Development Solutions
San Antonio, Texas, United States, 78209