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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

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
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
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

No publications provided

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:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013