Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.

Official Title
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Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects

Conditions
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Depression

Intervention / Treatment
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* Drug: BMS-866949
* Drug: BMS-866949
* Drug: BMS-866949
* Drug: BMS-866949
* Drug: BMS-866949
* Drug: BMS-866949
* Drug: BMS-866949
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male 18-55 Women not of child bearing potential, 18-55 Exclusion Criteria: History of or current treatment for psychiatric illnesses, substance abuse or dependence History of a clinically significant neurological disorder (e.g., history of stroke, head trauma, etc.)

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-866949 (Panel 1)<br> | Drug: BMS-866949<br>* (Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days<br>Drug: Placebo<br>* (Matching volume) - Oral Solution, Oral, once 14 days<br>|
| Experimental: BMS-866949 (Panel 2)<br> | Drug: BMS-866949<br>* (Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days<br>Drug: Placebo<br>* (Matching volume) - Oral Solution, Oral, once 14 days<br>|
| Experimental: BMS-866949 (Panel 3)<br> | Drug: BMS-866949<br>* (Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days<br>Drug: Placebo<br>* (Matching volume) - Oral Solution, Oral, once 14 days<br>|
| Experimental: BMS-866949 (Panel 4)<br> | Drug: BMS-866949<br>* (Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days<br>Drug: Placebo<br>* (Matching volume) - Oral Solution, Oral, once 14 days<br>|
| Experimental: BMS-866949 (Panel 5)<br> | Drug: BMS-866949<br>* (Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days<br>Drug: Placebo<br>* (Matching volume) - Oral Solution, Oral, once 14 days<br>|
| Experimental: BMS-866949 (Panel 6)<br> | Drug: BMS-866949<br>* (Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days<br>Drug: Placebo<br>* (Matching volume) - Oral Solution, Oral, once 14 days<br>|
| Experimental: BMS-866949 (Panel 7)<br> | Drug: BMS-866949<br>* (Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days<br>Drug: Placebo<br>* (Matching volume) - Oral Solution, Oral, once 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs |  | up to Day 14 +/- 2 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples |  | Blood samples will be taken up to 144 hour post-dose |