Safety Study of BMS-816336 in Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.

Official Title
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Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-816336 in Healthy Male Subjects

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent, Dyslipidemia

Intervention / Treatment
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* Drug: BMS-816336
* Drug: BMS-816336
* Drug: BMS-816336
* Drug: BMS-816336
* Drug: BMS-816336
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects BMI of 18 to 32 kg/m² Men only, ages 18-55 years Exclusion Criteria: Sexually active men not using effective birth control if their partners are WOCBP Any significant acute or chronic medical illness Family history of Gilbert's disease History of Pancreatitis Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EGG or clinical laboratory determinations QTc interval > 450 msec (corrected for heart rate using Fridericia's correction method, QTcF) Second- or third-degree A-V block or clinically relevant ECG abnormalities History of allergy to 11-β-HSD-1 inhibitors or related compounds Prior exposure to BMS-816336 Use of St. John's Wort (Hypericum) within 4 weeks prior to the first dose of study drug and throughout the study Use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration Use of any glucocorticoid topical creams within 4 weeks of study drug administration Use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMS-816336 or placebo (Panel 1)<br> | Drug: BMS-816336<br>* Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days<br>Drug: Placebo<br>* Suspension, Oral, 0 mg, Once on Day 1 only, 4 days<br>|
| Active Comparator: BMS-816336 or placebo (Panel 2)<br> | Drug: BMS-816336<br>* Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days<br>Drug: Placebo<br>* Suspension, Oral, 0 mg, Once on Day 1 only, 4 days<br>|
| Active Comparator: BMS-816336 or placebo (Panel 3)<br> | Drug: BMS-816336<br>* Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days<br>Drug: Placebo<br>* Suspension, Oral, 0 mg, Once on Day 1 only, 4 days<br>|
| Active Comparator: BMS-816336 or placebo (Panel 4)<br> | Drug: BMS-816336<br>* Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days<br>Drug: Placebo<br>* Suspension, Oral, 0 mg, Once on Day 1 only, 4 days<br>|
| Active Comparator: BMS-816336 or placebo (Panel 5)<br> | Drug: BMS-816336<br>* Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days<br>Drug: Placebo<br>* Suspension, Oral, 0 mg, Once on Day 1 only, 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to the investigational drug will be measured to assess safety and tolerability |  | Within 72 hours following dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the single dose Pharmacokinetics of BMS-816336 |  | During 72 hours following dosing |