Single Ascending Dose (BMS-813160) Study

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the safety and tolerability of single oral doses of BMS-813160 in healthy subjects

Official Title
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Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-813160 in Healthy Subjects

Conditions
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Accelerated Intimal Hyperplasia

Intervention / Treatment
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* Drug: BMS-813160
* Drug: BMS-813160
* Drug: BMS-813160
* Drug: BMS-813160
* Drug: BMS-813160
* Drug: BMS-813160
* Drug: [14C] BMS-813160
* Drug: Placebo
* Drug: BMS-813160
* Drug: BMS-813160


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women (not of child bearing potential) ages 18 to 45 Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Exclusion Criteria: Women of Child Bearing Potential Organ dysfunction or any clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 (BMS-813160 or placebo)<br> | Drug: BMS-813160<br>* Oral Solution, Oral, 5 mg, Single dose, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 2 (BMS-813160 or placebo)<br> | Drug: BMS-813160<br>* Oral Solution, Oral, 20 mg, Single dose, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 3 (BMS-813160 or placebo)<br> | Drug: BMS-813160<br>* Oral Solution, Oral, 60 mg, Single dose, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 4 (BMS-813160 or placebo)<br> | Drug: BMS-813160<br>* Oral Solution, Oral, 150 mg, Single dose, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 5 (BMS-813160 or placebo)<br> | Drug: BMS-813160<br>* Oral Solution, Oral, 300 mg, Single dose, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 6 (BMS-813160 or placebo)<br> | Drug: BMS-813160<br>* Oral Solution, Oral, 600 mg, Single Dose, 1 day<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 7 [14C] BMS-813160<br> | Drug: [14C] BMS-813160<br>* Oral Solution, Oral, 150 mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 8 (BMS-813160 or placebo)<br> | Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Single Dose, 1 day<br>Drug: BMS-813160<br>* Oral Solution, Oral, 1200 mg, Single dose, 1 day<br>|
| Active Comparator: Arm 9 (BMS-813160 or placebo)<br> | Drug: BMS-813160<br>* Oral Solution, Oral, 2000 mg, Single Dose, 1 day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events |  | Dosing through Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of BMS-813160 |  | 9 times after dosing | 
| Pharmacodynamics (Plasma MCP-1) |  | 9 times post dose | 
| Pharmacodynamics (Circulating monocytes) |  | 5 times post dose | 
| Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood) |  | 5 times post-dose |