Safety and Pharmacology Study of BMS-866949

NCT ID: NCT01124344

Last Updated: 2012-03-27

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-11-30

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

Detailed Description

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Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo or BMS-866949 (3 mg)

Panel 1: Healthy Male Subjects

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once Daily, 14 days

BMS-866949

Intervention Type DRUG

Oral Solution, Oral, 3 mg, Once Daily, 14 days

Placebo or BMS-866949 (10 mg)

Panel 2: Healthy Male Subjects

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once Daily, 14 days

BMS-866949

Intervention Type DRUG

Oral Solution, Oral, 10 mg, Once Daily, 14 days

Placebo or BMS-866949 (30 mg)

Panel 3: Healthy Male Subjects

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once Daily, 14 days

BMS-866949

Intervention Type DRUG

Oral Solution, Oral, 30 mg, Once Daily, 14 days

Placebo or BMS-866949 (45 mg)

Panel 4: Healthy Male Subjects

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once Daily, 14 days

BMS-866949

Intervention Type DRUG

Oral Solution, Oral, 45 mg, Once Daily, 14 days

Placebo or BMS-866949 (60 mg)

Panel 5: Healthy Male Subjects

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once Daily, 14 days

BMS-866949

Intervention Type DRUG

Oral Solution, Oral, 60 mg, Once Daily, 14 days

Placebo or BMS-866949 (90 mg)

Panel 6: Healthy Male Subjects

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once Daily, 14 days

BMS-866949

Intervention Type DRUG

Oral Solution, Oral, 90 mg, Once Daily, 14 days

Placebo or BMS-866949 (3 - 60 mg)

Panel 7: Females

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once Daily, 14 days

BMS-866949

Intervention Type DRUG

Oral Solution, Oral, 3-60 mg, Once Daily, 14 days

Interventions

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Placebo

Oral Solution, Oral, 0 mg, Once Daily, 14 days

Intervention Type DRUG

BMS-866949

Oral Solution, Oral, 3 mg, Once Daily, 14 days

Intervention Type DRUG

BMS-866949

Oral Solution, Oral, 10 mg, Once Daily, 14 days

Intervention Type DRUG

BMS-866949

Oral Solution, Oral, 30 mg, Once Daily, 14 days

Intervention Type DRUG

BMS-866949

Oral Solution, Oral, 45 mg, Once Daily, 14 days

Intervention Type DRUG

BMS-866949

Oral Solution, Oral, 60 mg, Once Daily, 14 days

Intervention Type DRUG

BMS-866949

Oral Solution, Oral, 90 mg, Once Daily, 14 days

Intervention Type DRUG

BMS-866949

Oral Solution, Oral, 3-60 mg, Once Daily, 14 days

Intervention Type DRUG

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Uppsala, , Sweden

Site Status

Countries

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Sweden

Related Links

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Other Identifiers

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2010-018461-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CN166-002

Identifier Type: -

Identifier Source: org_study_id

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