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The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-963272 compared to placebo in participants with nonalcoholic fatty liver disease (NAFLD) and high probability of advanced fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment (BMS-963272) Dosing Regimen 1 | Experimental |
| |
| Active Treatment (BMS-963272) Dosing Regimen 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-963272 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 166 days | |
| Incidence of serious adverse events (SAEs) | Up to 166 days | |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 166 days | |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 166 days | |
| Incidence of clinically significant changes in physical examination findings | Up to 166 days | |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval: The time from the onset of the P wave to the start of the QRS complex | Up to 166 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval | QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization | Up to 166 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | QT interval: Measured from the beginning of the QRS complex to the end of the T wave | Up to 166 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) sampling: Maximum observed plasma concentration (Cmax) | Day 1 and Day 84 | |
| Pharmacokinetic (PK) sampling: Time to maximum observed plasma concentration (Tmax) | Day 1 and Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cullman Clinical Trials | Cullman | Alabama | 35055 | United States | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Placebo matching BMS-963272 | Other | Specified dose on specified days |
|
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) |
| Up to 166 days |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry test | Up to 166 days |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 166 days |
| Incidence of clinically significant changes in clinical laboratory results: Coagulation tests | Up to 166 days |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to 46 days |
| Incidence of clinically significant changes in clinical laboratory results: Liver function tests | Up to 166 days |
| Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests | Up to 166 days |
| Pharmacokinetic (PK) sampling: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Day 1 and Day 84 |
| Trough observed plasma concentration (Ctrough) | Day 1, Day 15, Day 29, Day 57, and Day 84 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Arizona Liver Health - Tucson | Tucson | Arizona | 85712 | United States |
| Local Institution | Boca Raton | Florida | 33434 | United States |
| RecioMed Clinical Research Network | Boynton Beach | Florida | 33472 | United States |
| Local Institution | Miami | Florida | 33014 | United States |
| Advanced Pharma - Miami | Miami | Florida | 33147 | United States |
| Floridian Clinical Research | Miami Lakes | Florida | 33016 | United States |
| Local Institution | Port Orange | Florida | 32127 | United States |
| Local Institution | Bastrop | Louisiana | 71220 | United States |
| Local Institution | Biloxi | Mississippi | 39532 | United States |
| Local Institution | Kansas City | Missouri | 64131 | United States |
| Local Institution | Chattanooga | Tennessee | 37421 | United States |
| Local Institution | Germantown | Tennessee | 38138 | United States |
| Pinnacle Clinical Research - Austin | Austin | Texas | 78757 | United States |
| Local Institution | Edinburg | Texas | 78539 | United States |
| Local Institution | McAllen | Texas | 78504 | United States |
| Local Institution | San Antonio | Texas | 78215 | United States |
| Local Institution | San Antonio | Texas | 78229 | United States |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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