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The study is no longer required based on nonclinical drug data
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A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.
A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy SAD BMS-986318 or Placebo | Experimental | Single Ascending Dose (SAD) |
|
| Monotherapy MAD BMS-986318 or Placebo | Experimental | Multiple Ascending Dose (MAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986318 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of non-serious adverse events (AEs) | up to 30 days | |
| Incidence of Serious Adverse Events (SAE) | up to 30 days | |
| Incidence of AEs leading to discontinuation of study treatment | up to 30 days | |
| Physical Examination of height | up to 30 days | |
| Physical Examination of weight | up to 30 days | |
| Physical Examination of BMI | up to 30 days | |
| Assessment of body temperature | up to 30 days | |
| Assessment of respiratory rate | up to 30 days | |
| Assessment of blood pressure | up to 30 days | |
| Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities | up to 30 days | |
| Number of clinical significant changes in lab assessment of blood serum | up to 30 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences - Lenexa | Lenexa | Kansas | 66219 | United States |
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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 | Other | Placebo Matching BMS-986318 |
|
| Number of Clinically significant changes in assessment of blood |
| up to 30 days |
| Number of Clinically significant changes in lab assessment of urine | up to 30 days |
| FDA Safety Alerts and Recalls | View source |