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The purpose of this study is to evaluate the pharmacokinetics (PK) of xanomeline following administration of KarXT in CYP2D6 normal/extensive, intermediate, poor, and ultrarapid metabolizers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KarXT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xanomeline/ Trospium Chloride | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12)) | Up to Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Up to 28 days post last dose | |
| Number of participants with Serious Adverse Events (SAEs) | Up to 28 days post last dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain the NCT# and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Recruiting | Anaheim | California | 92801 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
See Plan Description
See Plan Description
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| Number of participants with physical examination abnormalities |
| Up to 28 days post last dose |
| Number of participants with vital sign abnormalities | Up to 28 days post last dose |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 28 days post last dose |
| Number of participants with clinical laboratory test abnormalities | Up to 28 days post last dose |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 28 days post last dose |
| Number of participants with AEs of Special Interest (AESIs) | Up to 28 days post last dose |
| ICON - Lenexa | Recruiting | Lenexa | Kansas | 66219-9746 | United States |
|
| ICON Development Solutions | Recruiting | San Antonio | Texas | 78209 | United States |
|
| ID | Term |
|---|---|
| C075257 | xanomeline |
| C003330 | trospium chloride |
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