Single Dose Study of BMS-820836

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses

Official Title
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Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-820836 in Healthy Subjects

Conditions
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Depression

Intervention / Treatment
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* Drug: BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836
* Drug: Placebo
* Drug: BMS-820836
* Drug: BMS-820836


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg Right-handed, non-ambidextrous subjects for Part 2 Men and women, ages 18 to 55 years, inclusive Exclusion Criteria: Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product WOCBP using a prohibited contraceptive method Women who are pregnant or breastfeeding Sexually active fertile men not using effective birth control if their partners are WOCBP Any significant acute or chronic medical illness Current or recent (within 3 months) gastrointestinal disease History of cholecystectomy Any major surgery within 4 weeks of study drug administration Any gastrointestinal surgery that could impact the absorption of study drug Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration Blood transfusion within 4 weeks of study drug administration Inability to tolerate/swallow oral medication Difficulty with venipuncture and/or poor venous access Self-reported smokers Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy) Confirmed resting supine systolic blood pressure > 130 mmHg Confirmed resting supine diastolic blood pressure > 80 mmHg Confirmed QT value ≥ 500 msec Confirmed QTc (Bazett) value ≥ 450 msec History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) History of peppermint allergies History of brain conditions (e.g. history of stroke, head trauma, etc.) History of or current psychiatric conditions History of claustrophobia

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMS-820836 (Part 1, Panel 1)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 0.025 mg, single dose, one dose<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, single dose, one dose<br>|
| Active Comparator: BMS-820836 (Part 1, Panel 2)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 0.1 mg, single dose, one dose<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, single dose, one dose<br>|
| Active Comparator: BMS-820836 (Part 1, Panel 3)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 0.25 mg, single dose, one dose<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, single dose, one dose<br>|
| Active Comparator: BMS-820836 (Part 1, Panel 4)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 0.5 mg, single dose, one dose<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, single dose, one dose<br>|
| Active Comparator: BMS-820836 (Part 1, Panel 5)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 1 mg, single dose, one dose<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, single dose, one dose<br>|
| Active Comparator: BMS-820836 (Part 1, Panel 6)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 2 mg, single dose, one dose<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, single dose, one dose<br>|
| Active Comparator: BMS-820836 (Part 1, Panel 7)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 3 mg, single dose, one dose<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, single dose, one dose<br>|
| Active Comparator: BMS-820836 (Part 1, Panel 8)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 5 mg, single dose, one dose<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, single dose, one dose<br>|
| Active Comparator: BMS-820836 (Part 1, Panel 9)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 8 mg, single dose, one dose<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, single dose, one dose<br>|
| Active Comparator: BMS-820836 (Part 2, Panel A)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 3 mg, single dose, one dose<br>|
| Active Comparator: BMS-820836 (Part 2, Panel B)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 0.5 mg, single dose, one dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of BMS-820836 following single-dose administration |  | Within 14 days of first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007 |  | Within 7 days of dosing | 
| To assess the pharmacodynamics of BMS-820836 |  | Within 48 hours of dosing |