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Xanomeline + Trospium Chloride for Healthy Subjects
Phase 1
Recruiting
Research Sponsored by Karuna Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy Adult Japanese Participants (Group A): Participants must be 19 to 55 years of age, inclusive. Both participant's biological parents are of ethnic Japanese ancestry. Must have a BMI of 18.0 to 32.0 kg/m2, and an eGFR of ≥ 90 mL/min/1.73m2 by the CKD-EPI equation at the screening visit.
Healthy Elderly Japanese Participants (Groups B and C): Participants must be 56 to 90 years of age, inclusive. Both participant's biological parents are of ethnic Japanese ancestry. Must have a BMI ≥ 18.0 and ≤ 35.0 kg/m2, and an eGFR of > 60 mL/min/1.73m2 by the CKD-EPI equation at the screening visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 30
Summary
This trial aims to evaluate the safety, side effects, and how the body processes a combination of KarXT and KarX-EC capsules compared to KarXT capsules alone in both healthy adult and elderly Japanese
Who is the study for?
This trial is for healthy adults and elderly people of Japanese ethnicity. Participants will be tested with different drug combinations to see how their bodies handle them. Those with certain health conditions or on conflicting medications may not qualify.
What is being tested?
The study is testing the safety and body's handling (pharmacokinetics) of a drug combo called KarXT + KarX-EC versus just KarXT, and also looking at how an acid-reducing medicine, omeprazole, affects this process in healthy participants.
What are the potential side effects?
Possible side effects might include digestive discomfort, dry mouth, blurred vision, constipation from trospium; xanomeline could cause nausea or dizziness. Omeprazole can lead to stomach pain or gas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy Japanese adult aged 19-55, with Japanese parents, a BMI of 18-32, and normal kidney function.
Select...
I am between 56 and 90 years old, of Japanese descent, with a healthy weight and kidney function.
Select...
I am 19-55 years old, with a BMI of 18-32 and healthy kidney function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 30
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Apparent total body clearance (CLT/F)
Apparent volume of distribution (Vz/F)
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
+8 moreSecondary study objectives
AUC(TAU)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Body weight
+13 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Group DExperimental Treatment3 Interventions
Group II: Group CExperimental Treatment3 Interventions
Group III: Group BExperimental Treatment2 Interventions
Group IV: Group AExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Omeprazole
2006
Completed Phase 4
~940
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Karuna TherapeuticsLead Sponsor
16 Previous Clinical Trials
3,956 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,523 Total Patients Enrolled