A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants
Phase 1
Recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT06605950
- Lead Sponsor
- Karuna Therapeutics
- Brief Summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of KarXT + KarX-EC capsules versus KarXT capsules in healthy adult and elderly participants of Japanese ethnicity and to assess the effect of multiple doses of omeprazole on the exposure of xanomeline and trospium administered as KarXT + KarX-EC capsules in healthy adult participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group D KarXT - Group C KarX-EC - Group D KarX-EC - Group A KarXT - Group A Placebo - Group B KarXT - Group B Placebo - Group C KarXT - Group C Placebo - Group D Omeprazole -
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) Up to 28 days post last dose Part 1
Number of participants with Serioues AEs (SAEs) Up to 28 days post last dose Part 1
Number of participants with vital sign abnormalities Up to 28 days post last dose Part 1
Body weight Up to 28 days post last dose Part 1
Number of participants with 12-lead electrocardiogram abnormalities Up to 28 days post last dose Part 1
Number of participants with physical examination abnormalities Up to 28 days post last dose Part 1
Number of participants with clinical laboratory assessment abnormalities Up to 28 days post last dose Part 1
Columbia-Suicide Severity Rating Scale (C-SSRS) On Day 30 Part 1
Maximum observed plasma concentration (Cmax) Up to Day 29 Part 2
Time of maximum observed plasma concentration (Tmax) Up to Day 29 Part 2
Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) Up to Day 29 Part 2
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) Up to Day 29 Part 2
Apparent total body clearance (CLT/F) Up to Day 29 Part 2
Apparent volume of distribution (Vz/F) Up to Day 29 Part 2
Terminal elimination half-life (T-HALF) Up to Day 29 Part 2
- Secondary Outcome Measures
Name Time Method Cmax Up to Day 29 Part 1
Tmax Up to Day 29 Part 1
AUC(0-24) Up to Day 29 Part 1
AUC(TAU) Up to Day 29 Part 1
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) Up to Day 29 Part 1
CLT/F Up to Day 29 Part 1
Vz/F Up to Day 29 Part 1
T-HALF Up to Day 29 Part 1
Number of participants with AEs Up to 28 days post last dose Part 2
Number of participants with SAEs Up to 28 days post last dose Part 2
Number of participants with vital sign abnormalities Up to 28 days post last dose Part 2
Body weight Up to 28 days post last dose Part 2
Number of participants with 12-lead electrocardiogram abnormalities Up to 28 days post last dose Part 2
Number of participants with physical examination abnormalities Up to 28 days post last dose Part 2
Number of participants with clinical laboratory assessment abnormalities Up to 28 days post last dose Part 2
C-SSRS On Day 30 Part 2
Trial Locations
- Locations (2)
Cenexel ACT (Anaheim Clinical Trials)
🇺🇸Anaheim, California, United States
Local Institution - 0002
🇺🇸Anaheim, California, United States