How CYP2D6 genetic differences change xanomeline levels after taking KarXT in healthy adults
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
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 |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Karuna Therapeutics, Inc., a Bristol Myers Squibb company Industry-sponsored |
| Locations | 3 sites (Anaheim, California and 2 other locations) |
| Trial ID | NCT07204418 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Pharmacogenetic PK studies of CYP2D6 have demonstrated genotype-related differences for many drugs, although published PK data specific to xanomeline are limited.
Eligibility criteria
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 this trial is running
Anaheim, California and 2 other locations
- Anaheim Clinical Trials — Anaheim, California, United States (Recruiting)
- ICON - Lenexa — Lenexa, Kansas, United States (Recruiting)
- ICON Development Solutions — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.