Single Dose Study of BMS-820836

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BMS-820836 (Part 1, Panel 1)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 0.025 mg, single dose, one dose

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, single dose, one dose

BMS-820836 (Part 1, Panel 2)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 0.1 mg, single dose, one dose

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, single dose, one dose

BMS-820836 (Part 1, Panel 3)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 0.25 mg, single dose, one dose

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, single dose, one dose

BMS-820836 (Part 1, Panel 4)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 0.5 mg, single dose, one dose

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, single dose, one dose

BMS-820836 (Part 1, Panel 5)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 1 mg, single dose, one dose

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, single dose, one dose

BMS-820836 (Part 1, Panel 6)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 2 mg, single dose, one dose

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, single dose, one dose

BMS-820836 (Part 1, Panel 7)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 3 mg, single dose, one dose

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, single dose, one dose

BMS-820836 (Part 1, Panel 8)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 5 mg, single dose, one dose

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, single dose, one dose

BMS-820836 (Part 1, Panel 9)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 8 mg, single dose, one dose

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, single dose, one dose

BMS-820836 (Part 2, Panel A)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 3 mg, single dose, one dose

BMS-820836 (Part 2, Panel B)

Group Type ACTIVE_COMPARATOR

BMS-820836

Intervention Type DRUG

Oral Solution, Oral, 0.5 mg, single dose, one dose

Interventions

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BMS-820836

Oral Solution, Oral, 0.025 mg, single dose, one dose

Intervention Type DRUG

BMS-820836

Oral Solution, Oral, 0.1 mg, single dose, one dose

Intervention Type DRUG

BMS-820836

Oral Solution, Oral, 0.25 mg, single dose, one dose

Intervention Type DRUG

BMS-820836

Oral Solution, Oral, 0.5 mg, single dose, one dose

Intervention Type DRUG

BMS-820836

Oral Solution, Oral, 1 mg, single dose, one dose

Intervention Type DRUG

BMS-820836

Oral Solution, Oral, 2 mg, single dose, one dose

Intervention Type DRUG

BMS-820836

Oral Solution, Oral, 3 mg, single dose, one dose

Intervention Type DRUG

BMS-820836

Oral Solution, Oral, 5 mg, single dose, one dose

Intervention Type DRUG

BMS-820836

Oral Solution, Oral, 8 mg, single dose, one dose

Intervention Type DRUG

Placebo

Oral Solution, Oral, 0 mg, single dose, one dose

Intervention Type DRUG

BMS-820836

Oral Solution, Oral, 3 mg, single dose, one dose

Intervention Type DRUG

BMS-820836

Oral Solution, Oral, 0.5 mg, single dose, one dose

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes