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The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe | Experimental |
| |
| Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986036 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) | Up to 29 days | |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] | Up to 29 days | |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036 | Up to 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 115 days | |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 85 days | |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States | ||
| ICON (LPRA) - Salt Lake |
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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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| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |
| Up to 85 days |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to 85 days |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 85 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 85 days |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 85 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 85 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | The PR interval is the time from the onset of the P wave to the start of the QRS complex. | Up to 85 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 85 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave | Up to 85 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval | Corrected QT interval using Fridericia's formula (QTcF) | Up to 85 days |
| Incidence of clinically significant changes in physical examination findings | Up to 85 days |
| Number of participants with local injection site reactions | Up to 57 days |
| Number of participants with Antibodies to fibroblast growth factor 21 (FGF21) | Up to 57 days |
| Number of participants with Antibodies to BMS-986036 | Up to 57 days |
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| C000630067 | Pegbelfermin |
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