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)
Overview
- Phase
- Phase 1
- Intervention
- KarXT
- Conditions
- Healthy Volunteers
- Sponsor
- Karuna Therapeutics
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Number of participants with Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group A
Intervention: KarXT
Group A
Intervention: Placebo
Group B
Intervention: KarXT
Group B
Intervention: Placebo
Group C
Intervention: KarXT
Group C
Intervention: KarX-EC
Group C
Intervention: Placebo
Group D
Intervention: KarXT
Group D
Intervention: KarX-EC
Group D
Intervention: Omeprazole
Outcomes
Primary Outcomes
Number of participants with Adverse Events (AEs)
Time Frame: Up to 28 days post last dose
Part 1
Number of participants with Serioues AEs (SAEs)
Time Frame: Up to 28 days post last dose
Part 1
Number of participants with vital sign abnormalities
Time Frame: Up to 28 days post last dose
Part 1
Body weight
Time Frame: Up to 28 days post last dose
Part 1
Number of participants with 12-lead electrocardiogram abnormalities
Time Frame: Up to 28 days post last dose
Part 1
Number of participants with physical examination abnormalities
Time Frame: Up to 28 days post last dose
Part 1
Number of participants with clinical laboratory assessment abnormalities
Time Frame: Up to 28 days post last dose
Part 1
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: On Day 30
Part 1
Maximum observed plasma concentration (Cmax)
Time Frame: Up to Day 29
Part 2
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to Day 29
Part 2
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time Frame: Up to Day 29
Part 2
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))
Time Frame: Up to Day 29
Part 2
Apparent total body clearance (CLT/F)
Time Frame: Up to Day 29
Part 2
Apparent volume of distribution (Vz/F)
Time Frame: Up to Day 29
Part 2
Terminal elimination half-life (T-HALF)
Time Frame: Up to Day 29
Part 2
Secondary Outcomes
- Tmax(Up to Day 29)
- AUC(0-24)(Up to Day 29)
- Cmax(Up to Day 29)
- AUC(TAU)(Up to Day 29)
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))(Up to Day 29)
- CLT/F(Up to Day 29)
- Vz/F(Up to Day 29)
- T-HALF(Up to Day 29)
- Number of participants with AEs(Up to 28 days post last dose)
- Number of participants with SAEs(Up to 28 days post last dose)
- Number of participants with vital sign abnormalities(Up to 28 days post last dose)
- Body weight(Up to 28 days post last dose)
- Number of participants with 12-lead electrocardiogram abnormalities(Up to 28 days post last dose)
- Number of participants with physical examination abnormalities(Up to 28 days post last dose)
- Number of participants with clinical laboratory assessment abnormalities(Up to 28 days post last dose)
- C-SSRS(On Day 30)