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 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)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: First line of the email MUST contain the NCT# and Site #.
Study Contact Backup
- Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Phone Number: 855-907-3286
- Email: Clinical.Trials@bms.com
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
- CenExel ACT (Anaheim Clinical Trials)
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Group A
|
Specified dose on specified days
Specified dose on specified days
Other Names:
|
|
Experimental: Group B
|
Specified dose on specified days
Specified dose on specified days
Other Names:
|
|
Experimental: Group C
|
Specified dose on specified days
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
|
|
Experimental: Group D
|
Specified dose on specified days
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with Adverse Events (AEs)
Time Frame: Up to 28 days post last dose
|
Part 1
|
Up to 28 days post last dose
|
|
Number of participants with Serioues AEs (SAEs)
Time Frame: Up to 28 days post last dose
|
Part 1
|
Up to 28 days post last dose
|
|
Number of participants with vital sign abnormalities
Time Frame: Up to 28 days post last dose
|
Part 1
|
Up to 28 days post last dose
|
|
Body weight
Time Frame: Up to 28 days post last dose
|
Part 1
|
Up to 28 days post last dose
|
|
Number of participants with 12-lead electrocardiogram abnormalities
Time Frame: Up to 28 days post last dose
|
Part 1
|
Up to 28 days post last dose
|
|
Number of participants with physical examination abnormalities
Time Frame: Up to 28 days post last dose
|
Part 1
|
Up to 28 days post last dose
|
|
Number of participants with clinical laboratory assessment abnormalities
Time Frame: Up to 28 days post last dose
|
Part 1
|
Up to 28 days post last dose
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: On Day 30
|
Part 1
|
On Day 30
|
|
Maximum observed plasma concentration (Cmax)
Time Frame: Up to Day 29
|
Part 2
|
Up to Day 29
|
|
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to Day 29
|
Part 2
|
Up to Day 29
|
|
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time Frame: Up to Day 29
|
Part 2
|
Up to Day 29
|
|
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))
Time Frame: Up to Day 29
|
Part 2
|
Up to Day 29
|
|
Apparent total body clearance (CLT/F)
Time Frame: Up to Day 29
|
Part 2
|
Up to Day 29
|
|
Apparent volume of distribution (Vz/F)
Time Frame: Up to Day 29
|
Part 2
|
Up to Day 29
|
|
Terminal elimination half-life (T-HALF)
Time Frame: Up to Day 29
|
Part 2
|
Up to Day 29
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cmax
Time Frame: Up to Day 29
|
Part 1
|
Up to Day 29
|
|
Tmax
Time Frame: Up to Day 29
|
Part 1
|
Up to Day 29
|
|
AUC(TAU)
Time Frame: Up to Day 29
|
Part 1
|
Up to Day 29
|
|
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
|
Up to Day 29
|
|
CLT/F
Time Frame: Up to Day 29
|
Part 1
|
Up to Day 29
|
|
Vz/F
Time Frame: Up to Day 29
|
Part 1
|
Up to Day 29
|
|
T-HALF
Time Frame: Up to Day 29
|
Part 1
|
Up to Day 29
|
|
Number of participants with AEs
Time Frame: Up to 28 days post last dose
|
Part 2
|
Up to 28 days post last dose
|
|
Number of participants with SAEs
Time Frame: Up to 28 days post last dose
|
Part 2
|
Up to 28 days post last dose
|
|
Number of participants with vital sign abnormalities
Time Frame: Up to 28 days post last dose
|
Part 2
|
Up to 28 days post last dose
|
|
Body weight
Time Frame: Up to 28 days post last dose
|
Part 2
|
Up to 28 days post last dose
|
|
Number of participants with 12-lead electrocardiogram abnormalities
Time Frame: Up to 28 days post last dose
|
Part 2
|
Up to 28 days post last dose
|
|
Number of participants with physical examination abnormalities
Time Frame: Up to 28 days post last dose
|
Part 2
|
Up to 28 days post last dose
|
|
Number of participants with clinical laboratory assessment abnormalities
Time Frame: Up to 28 days post last dose
|
Part 2
|
Up to 28 days post last dose
|
|
C-SSRS
Time Frame: On Day 30
|
Part 2
|
On Day 30
|
|
AUC(0-24)
Time Frame: Up to Day 29
|
Part 1
|
Up to Day 29
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Enzyme Inhibitors
- Neurotransmitter Agents
- Psychotropic Drugs
- Urological Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Cholinergic Agonists
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Parasympatholytics
- Parasympathomimetics
- Muscarinic Agonists
- Xanomeline
- Omeprazole
- Trospium chloride
Other Study ID Numbers
Other Study ID Numbers
- CN012-0030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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