Safety and Pharmacology Study of BMS-866949
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ClinicalTrials.gov Identifier: NCT01124344 |
Recruitment Status
:
Terminated
First Posted
: May 17, 2010
Last Update Posted
: March 27, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depression | Drug: Placebo Drug: BMS-866949 | Phase 1 |
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 |

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
|
- Assessment of safety by evaluating incidence of adverse events (AE) [ Time Frame: Over a period of 28 days (+/- 2 days) of first dose ]
- Assessment of pharmacokinetics by evaluating plasma concentration versus time data [ Time Frame: 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124344
Sweden | |
Local Institution | |
Uppsala, Sweden, 751 23 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
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 Key Record Dates |
Last Update Posted: | March 27, 2012 |
Last Verified: | March 2012 |
Additional relevant MeSH terms:
Depressive Disorder, Major Depressive Disorder Mood Disorders Mental Disorders |