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The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986308 compared to placebo in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Furosemide | Experimental |
| |
| Part B (SAD) | Experimental | Single Ascending Dose (SAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986308 | Drug | Specified dose on specified days |
| |
| Placebo (for BMS-986308) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Part B | Up to 19 days |
| Incidence of serious adverse events (SAEs) | Part B | Up to 19 days |
| Incidence of death | Part B | Up to 19 days |
| Incidence of adverse events (AEs) leading to discontinuation | Part B | Up to 19 days |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Part B | Up to 19 days |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Part B | Up to 19 days |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Part B | Up to 19 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Part B | Up to 19 days |
| Incidence of clinically significant changes in vital signs: Supine blood pressure |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Part A | Up to 14 days |
| Incidence of serious adverse events (SAEs) | Part A | Up to 72 days |
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 |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Lenexa | Kansas | 66219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39219444 | Derived | Soleman SI, Maya J, Levesque P, Mohammad A, Christopher L, Schumacher J, Nanduri A, Sivakumar P, Kozinn M, Costet P, Wang C, Richter J, Hawthorne D, Bui A, Rao VS, Dickerson D, Testani J, Ramirez-Valle F, Baribaud F, Murthy B, Merali S. First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986308: A Renal Outer Medullary Potassium Channel Inhibitor. Clin Pharmacol Ther. 2024 Dec;116(6):1627-1634. doi: 10.1002/cpt.3430. Epub 2024 Sep 2. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004487 | Edema |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Other |
Specified dose on specified days |
|
| Furosemide | Drug | Specified dose on specified days |
|
Part B |
| Up to 19 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Part B | Up to 19 days |
| Incidence of clinically significant changes in vital signs: Orthostatic hypotension measurements performed as per clinical research unit's standard operating procedure | Part B | Up to 19 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | Part B PR interval is the time from the onset of the P wave to the start of the QRS complex | Up to 19 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS | Part B QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to 19 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | Part B The QT interval is the time from the start of the Q wave to the end of the T wave | Up to 19 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF | Part B QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave | Up to 19 days |
| Incidence of clinically significant changes in cardiac telemetry | Part B | Up to 19 days |
| Incidence of clinically significant changes in physical examination findings | Part B | Up to 19 days |
| Incidence of death | Part A | Up to 72 days |
| Incidence of adverse events (AEs) leading to discontinuation | Part A | Up to 72 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Part A | Up to 14 days |
| Incidence of clinically significant changes in vital signs: Supine blood pressure | Part A | Up to 14 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Part A | Up to 14 days |
| Incidence of clinically significant changes in vital signs: Orthostatic hypotension measurements performed as per clinical research unit's standard operating procedure | Part A | Up to 3 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | Part A PR interval is the time from the onset of the P wave to the start of the QRS complex | Up to 14 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS | Part A QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to 14 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | Part A The QT interval is the time from the start of the Q wave to the end of the T wave | Up to 14 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF | Part A QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave | Up to 14 days |
| Incidence of clinically significant changes in cardiac telemetry | Part A | Up to 3 days |
| Incidence of clinically significant changes in physical examination findings | Part A | Up to 14 days |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |