How CYP2D6 genetic differences change xanomeline levels after taking KarXT in healthy adults
Official title: 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
Run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company · NCT07204418 · Data updated 2026-11-12
This test will see if genetic differences in CYP2D6 change the amount of xanomeline in the blood after healthy adults take KarXT.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Karuna Therapeutics, Inc., a Bristol Myers Squibb company Industry-sponsored |
| Locations | 3 sites (Anaheim, California and 2 other locations) |
| Status | Recruiting |
| Started | October 13, 2025 |
| Main results expected | December 3, 2026 |
| Study ends | December 3, 2026 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07204418 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults with a BMI between 18 and 32 who are classified as normal/extensive, intermediate, poor, or ultrarapid CYP2D6 metabolizers and able to attend clinic visits are ideal candidates.
✕Probably not a fit
People seeking treatment for a medical condition are unlikely to receive therapeutic benefit because this is a pharmacokinetic study in healthy volunteers.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this Phase 1 trial, healthy adult volunteers are genotyped for CYP2D6 and grouped as normal/extensive, intermediate, poor, or ultrarapid metabolizers. Participants receive KarXT (xanomeline with trospium chloride) and have blood samples collected over time to measure xanomeline pharmacokinetics. The study compares drug exposure and clearance across the CYP2D6 phenotype groups. Eligibility includes healthy males and females with BMI 18.0–32.0 kg/m2 and no clinically significant organ dysfunction.
Why it matters
Potential benefit: If successful, the results could help personalize xanomeline dosing based on CYP2D6 genotype to improve safety and effectiveness.
How similar studies have gone: Pharmacogenetic PK studies of CYP2D6 have demonstrated genotype-related differences for many drugs, although published PK data specific to xanomeline are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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ICON - Lenexa
Lenexa, Kansas, United States Recruiting -
Local Institution - 0003
Anaheim, California, United States Completed -
Local Institution - 0001
San Antonio, Texas, United States Completed
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.