Safety and Pharmacology Study of BMS-866949

March 26, 2012 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Terminated

Conditions

Major Depression

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Sweden
- - Uppsala, Sweden, 751 23
    - Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

Number of Arms

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

May 13, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (ESTIMATE)

May 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CN166-002
2010-018461-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Safety and Pharmacology Study of BMS-866949

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Major Depression

Clinical Trials on Placebo

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