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Completed

NCT Number: NCT06605950

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

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.

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Key information

Conditions

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cenexel ACT (Anaheim Clinical Trials)

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KarXT

Drug

Specified dose on specified days

Other names: BMS-986510, Xanomeline/Trospium Chloride

KarX-EC

Drug

Specified dose on specified days

Other names: BMS-986519, Xanomeline Enteric-coated

Placebo

Drug

Specified dose on specified days

Omeprazole

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to 28 days post last dose

    Part 1

  2. Number of participants with Serioues AEs (SAEs)

    Time frame: Up to 28 days post last dose

    Part 1

  3. Number of participants with vital sign abnormalities

    Time frame: Up to 28 days post last dose

    Part 1

  4. Body weight

    Time frame: Up to 28 days post last dose

    Part 1

  5. Number of participants with 12-lead electrocardiogram abnormalities

    Time frame: Up to 28 days post last dose

    Part 1

  6. Number of participants with physical examination abnormalities

    Time frame: Up to 28 days post last dose

    Part 1

  7. Number of participants with clinical laboratory assessment abnormalities

    Time frame: Up to 28 days post last dose

    Part 1

  8. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: On Day 30

    Part 1

  9. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 29

    Part 2

  10. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to Day 29

    Part 2

  11. Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

    Time frame: Up to Day 29

    Part 2

  12. Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))

    Time frame: Up to Day 29

    Part 2

  13. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 29

    Part 2

  14. Apparent volume of distribution (Vz/F)

    Time frame: Up to Day 29

    Part 2

  15. Terminal elimination half-life (T-HALF)

    Time frame: Up to Day 29

    Part 2

Secondary outcomes

  1. Cmax

    Time frame: Up to Day 29

    Part 1

  2. Tmax

    Time frame: Up to Day 29

    Part 1

  3. AUC(0-24)

    Time frame: Up to Day 29

    Part 1

  4. AUC(TAU)

    Time frame: Up to Day 29

    Part 1

  5. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to Day 29

    Part 1

  6. CLT/F

    Time frame: Up to Day 29

    Part 1

  7. Vz/F

    Time frame: Up to Day 29

    Part 1

  8. T-HALF

    Time frame: Up to Day 29

    Part 1

  9. Number of participants with AEs

    Time frame: Up to 28 days post last dose

    Part 2

  10. Number of participants with SAEs

    Time frame: Up to 28 days post last dose

    Part 2

  11. Number of participants with vital sign abnormalities

    Time frame: Up to 28 days post last dose

    Part 2

  12. Body weight

    Time frame: Up to 28 days post last dose

    Part 2

  13. Number of participants with 12-lead electrocardiogram abnormalities

    Time frame: Up to 28 days post last dose

    Part 2

  14. Number of participants with physical examination abnormalities

    Time frame: Up to 28 days post last dose

    Part 2

  15. Number of participants with clinical laboratory assessment abnormalities

    Time frame: Up to 28 days post last dose

    Part 2

  16. C-SSRS

    Time frame: On Day 30

    Part 2

Sponsors and collaborators

Lead sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 20, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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