Status:
COMPLETED
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
Lead Sponsor:
Karuna Therapeutics
Conditions:
Healthy Volunteers
Eligibility:
All Genders
19-90 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06605950
Start Date
October 1 2024
End Date
May 31 2025
Last Update
July 4 2025
Active Locations (1)
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1
Cenexel ACT (Anaheim Clinical Trials)
Anaheim, California, United States, 92801