Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes.

Official Title
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Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-820132 in Subjects With Type 2 Diabetes on Background Therapy of Metformin

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Drug: BMS-820132
* Drug: BMS-820132
* Drug: BMS-820132
* Drug: BMS-820132
* Drug: BMS-820132
* Drug: BMS-820132
* Drug: BMS-820132
* Drug: BMS-820132
* Drug: BMS-820132
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile) Diagnosis of type 2 diabetes treated with metformin monotherapy on a stable regimen for at least 2 months Body Mass Index (BMI) of 18 to 40 kg/m2 Fasting glucose in the range of 100-250 mg/dL Hemoglobin A1c (HbA1c) in the range of 6.5% -9.5% Exclusion Criteria: Clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, or depression Past history of diabetic ketoacidosis and/or C-peptide < 1.0 ng/mL, hyperosmolar nonketotic syndrome, lactic acidosis, or recurrent hypoglycemia Any major surgery within 4 weeks of study drug administration Any gastrointestinal surgery that could impact upon the absorption of study drug Smoking more than 10 cigarettes per day Recent drug or alcohol abuse Women who are pregnant or breastfeeding Positive urine screen for drugs of abuse Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMS-820132 (0.3 mg) or Placebo<br> | Drug: BMS-820132<br>* Oral Solution, Oral, 0.3 mg, once daily, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0mg, once daily, 1 day<br>|
| Active Comparator: BMS-820132 (1.0 mg) or Placebo<br> | Drug: BMS-820132<br>* Oral Solution, Oral, 1.0 mg, once daily, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0mg, once daily, 1 day<br>|
| Active Comparator: BMS-820132 (3 mg) or Placebo<br> | Drug: BMS-820132<br>* Oral Solution, Oral, 3 mg, once daily, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0mg, once daily, 1 day<br>|
| Active Comparator: BMS-820132 (10 mg) or Placebo<br> | Drug: BMS-820132<br>* Oral Solution, Oral, 10 mg, once daily, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0mg, once daily, 1 day<br>|
| Active Comparator: BMS-820132 (30 mg) or Placebo<br> | Drug: BMS-820132<br>* Oral Solution, Oral, 30 mg, once daily, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0mg, once daily, 1 day<br>|
| Active Comparator: BMS-820132 (75 mg) or Placebo<br> | Drug: BMS-820132<br>* Oral Solution, Oral , 75 mg, once daily, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0mg, once daily, 1 day<br>|
| Active Comparator: BMS-820132 (150 mg) or Placebo<br> | Drug: BMS-820132<br>* Oral Solution, Oral, 150 mg, once daily, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0mg, once daily, 1 day<br>|
| Active Comparator: BMS-820132 (300 mg) or Placebo<br> | Drug: BMS-820132<br>* Oral Solution, Oral, 300 mg, once daily, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0mg, once daily, 1 day<br>|
| Active Comparator: BMS-820132 (TBD) or Placebo<br> | Drug: BMS-820132<br>* Capsule, Oral, (TBD), once daily, 2 days<br>Drug: Placebo<br>* Capsule, Oral, (TBD), once daily, 2 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments |  | Within 5 days of study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to the investigational drug and its metabolites |  | Within 2 days after study drug administration | 
| Pharmacodynamic activity of the investigational drug on biomarkers |  | Within 2 days after study drug administration | 
| Excretion of the investigational drug and metabolites from the body |  | Within 2 days after study drug administration |