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Safety and Pharmacology Study of BMS-866949

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01124344
First Posted: May 17, 2010
Last Update Posted: March 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable

Condition Intervention Phase
Major Depression Drug: Placebo Drug: BMS-866949 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 47
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


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

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 Submitted: May 13, 2010
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