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

NCT06605950 | Completed Phase 1 FDA Drug

• 1 other identifier: CN012-0030
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Japanese; Elderly; Adult; Healthy; Pharmacokinetics; BMS-986510; BMS-986519; KarXT; Omeprazole; Drug interaction

Outcome Measures

Primary Outcomes (15)

• Number of participants with Adverse Events (AEs)

  Part 1

  Up to 28 days post last dose

• Number of participants with Serioues AEs (SAEs)

  Part 1

  Up to 28 days post last dose

• Number of participants with vital sign abnormalities

  Part 1

  Up to 28 days post last dose

• Body weight

  Part 1

  Up to 28 days post last dose

• Number of participants with 12-lead electrocardiogram abnormalities

  Part 1

  Up to 28 days post last dose

• Number of participants with physical examination abnormalities

  Part 1

  Up to 28 days post last dose

• Number of participants with clinical laboratory assessment abnormalities

  Part 1

  Up to 28 days post last dose

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Part 1

  On Day 30

• Maximum observed plasma concentration (Cmax)

  Part 2

  Up to Day 29

• Time of maximum observed plasma concentration (Tmax)

  Part 2

  Up to Day 29

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

  Part 2

  Up to Day 29

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

  Part 2

  Up to Day 29

• Apparent total body clearance (CLT/F)

  Part 2

  Up to Day 29

• Apparent volume of distribution (Vz/F)

  Part 2

  Up to Day 29

• Terminal elimination half-life (T-HALF)

  Part 2

  Up to Day 29

Secondary Outcomes (16)

• Cmax

  Up to Day 29

• Tmax

  Up to Day 29

• AUC(0-24)

  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

Study Arms (4)

Group A

EXPERIMENTAL

Drug: KarXT; Drug: Placebo

Group B

EXPERIMENTAL

Drug: KarXT; Drug: Placebo

Group C

EXPERIMENTAL

Drug: KarXT; Drug: KarX-EC; Drug: Placebo

Group D

EXPERIMENTAL

Drug: KarXT; Drug: KarX-EC; Drug: Omeprazole

Interventions

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510, Xanomeline/Trospium Chloride

Group A; Group B; Group C; Group D

KarX-EC DRUG

Specified dose on specified days

Also known as: BMS-986519, Xanomeline Enteric-coated

Group C; Group D

Placebo DRUG

Specified dose on specified days

Group A; Group B; Group C

Omeprazole DRUG

Specified dose on specified days

Group D

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karuna Therapeutics: lead

Study Sites (1)

Cenexel ACT (Anaheim Clinical Trials)

Anaheim, California, 92801, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

xanomeline; trospium chloride; Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1 of this study is double-blind while Part 2 is open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: October 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)