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

Part of paid clinical trials in Anaheim, California.

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID
NCT06605950
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
19 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • KarXT — DRUG
    Specified dose on specified days
  • KarX-EC — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified dose on specified days
  • Omeprazole — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Jun 2025
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
78 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
  • Experimental: Group B
  • Experimental: Group C
  • Experimental: Group D

Primary Outcome Measure

Number of participants with Adverse Events (AEs) [ Time Frame: Up to 28 days post last dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cenexel ACT (Anaheim Clinical Trials)AnaheimCalifornia92801-

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By research site
Cenexel ACT (Anaheim Clinical Trials)· Anaheim, CA

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