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Healthy VolunteersPhase 1NCT06605950

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

A Phase 1 study testing KarXT, KarX-EC and Omeprazole in people with Healthy Volunteers, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
KarXT, KarX-EC and Omeprazole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteUnited States
Study dates
1 Oct 2024to 31 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Inclusion Criteria for Healthy Adult Japanese Participants (Group A):.
  • Healthy adult participants must be 19 to 55 years of age, inclusive.
  • Both participant's biological parents are of ethnic Japanese ancestry. Participants must be first generation Japanese.
  • Must have a body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive), at the time of signing the ICF.
  • 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):.
Show all 15Show fewer
  • Healthy elderly participants must be 56 to 90 years of age, inclusive.
  • Both participant's biological parents are of ethnic Japanese ancestry. Participants must be first generation Japanese.
  • Must have a BMI ≥ 18.0 and ≤ 35.0 kg/m2 (inclusive), at the time of signing the ICF.
  • 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.
  • Participants with any ethnicity can be included.
  • Must have a BMI of 18.0 to 32.0 kg/m2 (inclusive), at the time of signing the ICF.
  • Must have an eGFR of ≥ 90 mL/min/1.73m2 by the CKD-EPI equation at the screening visit. One repeat measurement is allowed.

Who cannot join

  • Exclusion Criteria for All Participants (Groups A, B, C, and D):.
  • 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.
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
  • Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cenexel ACT (Anaheim Clinical Trials)

    Anaheim, California, 92801

Other trials in United States

About this study

Official 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)

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.

Being tested
KarXT, KarX-EC, Placebo, Omeprazole
Keywords
Japanese, Elderly, Adult, Healthy, Pharmacokinetics, BMS-986510, BMS-986519, KarXT, Omeprazole, Drug interaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KarXTDrug

    Also called BMS-986510, Xanomeline/Trospium Chloride

    Specified dose on specified days

  • KarX-ECDrug

    Also called BMS-986519, Xanomeline Enteric-coated

    Specified dose on specified days

  • PlaceboDrug

    Specified dose on specified days

  • OmeprazoleDrug

    Specified dose on specified days

Study groups in NCT06605950
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Drug: KarXT; Drug: Placebo
Group BExperimentalNot described
Receives: Drug: KarXT; Drug: Placebo
Group CExperimentalNot described
Receives: Drug: KarXT; Drug: KarX-EC; Drug: Placebo
Group DExperimentalNot described
Receives: Drug: KarXT; Drug: KarX-EC; Drug: Omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Adverse Events (AEs)

    Part 1

    Measured: Up to 28 days post last dose

  2. Number of participants with Serioues AEs (SAEs)

    Part 1

    Measured: Up to 28 days post last dose

  3. Number of participants with vital sign abnormalities

    Part 1

    Measured: Up to 28 days post last dose

  4. Body weight

    Part 1

    Measured: Up to 28 days post last dose

  5. Number of participants with 12-lead electrocardiogram abnormalities

    Part 1

    Measured: Up to 28 days post last dose

  6. Number of participants with physical examination abnormalities

    Part 1

    Measured: Up to 28 days post last dose

  7. Number of participants with clinical laboratory assessment abnormalities

    Part 1

    Measured: Up to 28 days post last dose

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

    Part 1

    Measured: On Day 30

  9. Maximum observed plasma concentration (Cmax)

    Part 2

    Measured: Up to Day 29

  10. Time of maximum observed plasma concentration (Tmax)

    Part 2

    Measured: Up to Day 29

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

    Part 2

    Measured: Up to Day 29

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

    Part 2

    Measured: Up to Day 29

  13. Apparent total body clearance (CLT/F)

    Part 2

    Measured: Up to Day 29

  14. Apparent volume of distribution (Vz/F)

    Part 2

    Measured: Up to Day 29

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

    Part 2

    Measured: Up to Day 29

Secondary outcomes (16)

  1. Cmax

    Part 1

    Measured: Up to Day 29

  2. Tmax

    Part 1

    Measured: Up to Day 29

  3. AUC(0-24)

    Part 1

    Measured: Up to Day 29

  4. AUC(TAU)

    Part 1

    Measured: Up to Day 29

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

    Part 1

    Measured: Up to Day 29

  6. CLT/F

    Part 1

    Measured: Up to Day 29

  7. Vz/F

    Part 1

    Measured: Up to Day 29

  8. T-HALF

    Part 1

    Measured: Up to Day 29

  9. Number of participants with AEs

    Part 2

    Measured: Up to 28 days post last dose

  10. Number of participants with SAEs

    Part 2

    Measured: Up to 28 days post last dose

  11. Number of participants with vital sign abnormalities

    Part 2

    Measured: Up to 28 days post last dose

  12. Body weight

    Part 2

    Measured: Up to 28 days post last dose

  13. Number of participants with 12-lead electrocardiogram abnormalities

    Part 2

    Measured: Up to 28 days post last dose

  14. Number of participants with physical examination abnormalities

    Part 2

    Measured: Up to 28 days post last dose

  15. Number of participants with clinical laboratory assessment abnormalities

    Part 2

    Measured: Up to 28 days post last dose

  16. C-SSRS

    Part 2

    Measured: On Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2024
  2. Study start1 Oct 2024
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06605950
Sponsor's protocol ID
CN012-0030
Status last verified
Jun 2025
First submitted
18 Sep 2024
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KarXT, KarX-EC and Omeprazole in people with Healthy Volunteers, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Adverse Events (AEs) (time frame: Up to 28 days post last dose). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06605950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.

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