Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Safety and Pharmacology Study of BMS-866949

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01124344
First received: May 13, 2010
Last updated: March 26, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Assessment of pharmacodynamics by evaluating brain transporter occupancy [ Time Frame: Over a period 28 days (+/- 2 days) of first dose ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01124344     History of Changes
Other Study ID Numbers: CN166-002  2010-018461-38 
Study First Received: May 13, 2010
Last Updated: March 26, 2012
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 28, 2016