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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1321-3511 | Other Identifier | WHO |
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The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, and to explore the effect of food after multiple doses of selected prototypes in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
| |
| Part 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xanomeline/Trospium Chloride Capsule | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to Day 23 | |
| Time of maximum observed concentration (Tmax) | Up to Day 23 | |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 23 | |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 23 | |
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Up to Day 23 | |
| Concentration at the end of a dosing interval (Ctau) | Up to Day 23 | |
| Apparent total body clearance (CLT/F) | Up to Day 23 | |
| Effective elimination half-life during dosing interval (T-HALF(eff)) | Up to Day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | Up to 30 days after final dose of study intervention | |
| Number of participants with Serious Adverse Events (SAEs) | Up to 30 days after final dose of study intervention |
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Inclusion 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 NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Recruiting | Nottingham | Nottinghamshire | NG1 6JS | United Kingdom |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | 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 Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Xanomeline Enteric Capsule | Drug | Specified dose on specified days |
|
|
| Trospium Chloride | Drug | Specified dose on specified days |
|
|
| Number of participants with Adverse Events of Special Interest (AESIs) | Up to 30 days after final dose of study intervention |
| Number of participants with AEs leading to discontinuation | Up to 30 days after final dose of study intervention |
| Number of participants with vital signs abnormalities | Up to 30 days after final dose of study intervention |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 30 days after final dose of study intervention |
| Number of participants with physical examination abnormalities | Up to 30 days after final dose of study intervention |
| Number of participants with clinical laboratory abnormalities | Up to 30 days after final dose of study intervention |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 25 |
| Geometric mean ratio of Cmax | Up to Day 23 |
| Geometric mean ratio of AUC(0-T) | Up to Day 23 |
| Geometric mean ratio of AUC(INF) | Up to Day 23 |
| Geometric mean ratio of area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Up to Day 23 |
| ID | Term |
|---|---|
| C075257 | xanomeline |
| C003330 | trospium chloride |
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