Safety and Pharmacology Study of BMS-866949

Study Overview
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Brief Summary
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The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable

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

Conditions
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Major Depression

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Panels 1-6: Healthy Male Subjects Panel 7: Females Ages 21 to 55, inclusive Body Mass Index (BMI) of 18 to 32 kg/m², inclusive Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Exclusion Criteria: History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg) History or family history of psychiatric disorder Current treatment with prescription medication Exposure to any investigational drug or placebo within 12 weeks of study drug administration

Ages Eligible for Study
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Minimum Age: 21 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo or BMS-866949 (3 mg)<br>Panel 1: Healthy Male Subjects | Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once Daily, 14 days<br>Drug: BMS-866949<br>* Oral Solution, Oral, 3 mg, Once Daily, 14 days<br>|
| Active Comparator: Placebo or BMS-866949 (10 mg)<br>Panel 2: Healthy Male Subjects | Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once Daily, 14 days<br>Drug: BMS-866949<br>* Oral Solution, Oral, 10 mg, Once Daily, 14 days<br>|
| Active Comparator: Placebo or BMS-866949 (30 mg)<br>Panel 3: Healthy Male Subjects | Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once Daily, 14 days<br>Drug: BMS-866949<br>* Oral Solution, Oral, 30 mg, Once Daily, 14 days<br>|
| Active Comparator: Placebo or BMS-866949 (45 mg)<br>Panel 4: Healthy Male Subjects | Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once Daily, 14 days<br>Drug: BMS-866949<br>* Oral Solution, Oral, 45 mg, Once Daily, 14 days<br>|
| Active Comparator: Placebo or BMS-866949 (60 mg)<br>Panel 5: Healthy Male Subjects | Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once Daily, 14 days<br>Drug: BMS-866949<br>* Oral Solution, Oral, 60 mg, Once Daily, 14 days<br>|
| Active Comparator: Placebo or BMS-866949 (90 mg)<br>Panel 6: Healthy Male Subjects | Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once Daily, 14 days<br>Drug: BMS-866949<br>* Oral Solution, Oral, 90 mg, Once Daily, 14 days<br>|
| Active Comparator: Placebo or BMS-866949 (3 - 60 mg)<br>Panel 7: Females | Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once Daily, 14 days<br>Drug: BMS-866949<br>* Oral Solution, Oral, 3-60 mg, Once Daily, 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety by evaluating incidence of adverse events (AE) |  | Over a period of 28 days (+/- 2 days) of first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetics by evaluating plasma concentration versus time data |  | Over a period 28 days (+/- 2 days) of first dose | 
| Assessment of pharmacodynamics by evaluating brain transporter occupancy |  | Over a period 28 days (+/- 2 days) of first dose |