Safety and Pharmacology Study of BMS-866949

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Major Depression	Drug: Placebo; Drug: BMS-866949	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	47 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-866949 in Healthy Subjects
Study Start Date :	May 2010
Actual Primary Completion Date :	November 2011
Actual Study Completion Date :	November 2011

Arms and Interventions

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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
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, 10 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, 30 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, 45 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, 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, 90 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, 3-60 mg, Once Daily, 14 days

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Sweden
Local Institution
Uppsala, Sweden, 751 23

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

BMS Clinical Trials Disclosure 

Investigator Inquiry form 

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm 

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01124344 History of Changes
Other Study ID Numbers:	CN166-002; 2010-018461-38 ( EudraCT Number )
First Posted:	May 17, 2010
Last Update Posted:	March 27, 2012
Last Verified:	March 2012

Additional relevant MeSH terms:

Depressive Disorder, Major; Depressive Disorder; Mood Disorders; Mental Disorders