Assessing the safety and pharmacokinetics of xanomeline with trospium in healthy Japanese adults and elderly
A 2-Part, Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Dual-burst Release of Xanomeline With Immediate-Release Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity (Part 1) and an Open-label Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Dual-burst Release of Xanomeline With Immediate-Release Trospium Chloride in Healthy Adult Participants (Part 2)
This study is testing how safe and effective a new combination of medications is for healthy Japanese adults and older people, while also looking at how another drug affects their absorption.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 19 Years to 90 Years |
| Sex | All |
| Sponsor | Karuna Therapeutics Industry-sponsored |
| Locations | 2 sites (Anaheim, California and 1 other locations) |
| Trial ID | NCT06605950 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of xanomeline combined with trospium chloride in healthy adult and elderly participants of Japanese ethnicity. It compares the effects of multiple doses of KarXT and KarX-EC capsules against a placebo. Additionally, the study investigates how omeprazole influences the pharmacokinetics of xanomeline and trospium in healthy adults. Participants will be closely monitored for any adverse effects and changes in drug absorption.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 19 to 55 or elderly individuals aged 56 to 90 of first-generation Japanese ancestry.
Not a fit: Patients who are not of Japanese ethnicity or those with significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safe use and dosing of xanomeline and trospium in Japanese populations, potentially leading to better treatment options.
How similar studies have performed: While this study focuses on a specific ethnic group, similar pharmacokinetic studies have shown promise in understanding drug interactions and safety profiles.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Inclusion Criteria for Healthy Adult Japanese Participants (Group A):. * Healthy adult participants must be 19 to 55 years of age, inclusive. i) Both participant's biological parents are of ethnic Japanese ancestry. Participants must be first generation Japanese. ii) Must have a body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive), at the time of signing the ICF. iii) Must have an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min/1.73m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the screening visit. One repeat measurement is allowed. * Inclusion Criteria for Healthy Elderly Japanese Participants (Groups B and C):. * Healthy elderly participants must be 56 to 90 years of age, inclusive. i) Both participant's biological parents are of ethnic Japanese ancestry. Participants must be first generation Japanese. ii) Must have a BMI ≥ 18.0 and ≤ 35.0 kg/m2 (inclusive), at the time of signing the ICF. iii) Must have an eGFR of \> 60 mL/min/1.73m2 by the CKD-EPI equation at the screening visit. One repeat measurement is allowed. * Inclusion Criteria for Healthy Adult Participants (Groups D):. * Healthy adult participants must be 19 to 55 years of age, inclusive. i) Participants with any ethnicity can be included. ii) Must have a BMI of 18.0 to 32.0 kg/m2 (inclusive), at the time of signing the ICF. iii) Must have an eGFR of ≥ 90 mL/min/1.73m2 by the CKD-EPI equation at the screening visit. One repeat measurement is allowed. Exclusion Criteria - Exclusion Criteria for All Participants (Groups A, B, C, and D):. i) Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. ii) History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. iii) Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1. iv) History of cancer that has not been in full remission for \>5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for \> 1 year prior to the screening visit). * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Anaheim, California and 1 other locations
- Cenexel ACT (Anaheim Clinical Trials) — Anaheim, California, United States (Recruiting)
- Local Institution - 0002 — Anaheim, California, United States (Withdrawn)
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.