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The purpose of this study is to evaluate the safety profile, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) following single and multiple oral doses of BMS-963272 in healthy subjects.
Study Classification: Safety, PK/PD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A SAD: BMS-963272 or Placebo | Experimental | BMS-963272 or Placebo oral capsule on specific days |
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| Part B MAD: BMS-963272 or Placebo | Experimental | BMS-963272 or Placebo oral capsule on specific days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-963272 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single oral dose of BMS-963272 in healthy overweight and obese subjects is measured by adverse events, Serious adverse events, vital signs, laboratory assessments and ECG | Up to 10 days | |
| Safety and tolerability of multiple oral doses of BMS-963272 in healthy overweight and obese subjects is measured by adverse events, Serious adverse events, vital signs, laboratory assessments and ECG | With in 18 days |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat.
i)PR ≥ 210 msec ii)QRS ≥ 120 msec iii)QT ≥ 500 msec iv)QTcF ≥ 450 msec
Positive urine screen for drugs of abuse
Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
Moderate anemia (hemoglobin < 11 g/dL for men and < 10 g/dL for women)
aspartate aminotransferase (AST) > 1.3x ULN
alanine aminotransferase (ALT) > 1.3x ULN
Total bilirubin > 1.3x upper limit of normal (ULN)
estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73 m2 (calculated using CKD-EPI formula)
HbA1c > 6.5%
Fasting total cholesterol > 300 mg/dl
Fasting triglycerides > 400 mg/dl
Systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 95 mm Hg, confirmed by repeat measurement
History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
History of lactose intolerance
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ppd Development, Lp | Austin | Texas | 78744 | United States |
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| Drug |
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