Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00949767
First received: July 29, 2009
Last updated: January 24, 2011
Last verified: March 2010
  Purpose

The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs [ Time Frame: up to Day 14 +/- 2 days post-dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples [ Time Frame: Blood samples will be taken up to 144 hour post-dose ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-866949 (Panel 1) Drug: BMS-866949
(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
Drug: Placebo
(Matching volume) - Oral Solution, Oral, once 14 days
Experimental: BMS-866949 (Panel 2) Drug: BMS-866949
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
Drug: Placebo
(Matching volume) - Oral Solution, Oral, once 14 days
Experimental: BMS-866949 (Panel 3) Drug: BMS-866949
(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
Drug: Placebo
(Matching volume) - Oral Solution, Oral, once 14 days
Experimental: BMS-866949 (Panel 4) Drug: BMS-866949
(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
Drug: Placebo
(Matching volume) - Oral Solution, Oral, once 14 days
Experimental: BMS-866949 (Panel 5) Drug: BMS-866949
(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
Drug: Placebo
(Matching volume) - Oral Solution, Oral, once 14 days
Experimental: BMS-866949 (Panel 6) Drug: BMS-866949
(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
Drug: Placebo
(Matching volume) - Oral Solution, Oral, once 14 days
Experimental: BMS-866949 (Panel 7) Drug: BMS-866949
(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
Drug: Placebo
(Matching volume) - Oral Solution, Oral, once 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male 18-55
  • Women not of child bearing potential, 18-55

Exclusion Criteria:

  • History of or current treatment for psychiatric illnesses, substance abuse or dependence
  • History of a clinically significant neurological disorder (e.g., history of stroke, head trauma, etc.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949767

Locations
Sweden
Local Institution
Uppsala, Sweden, 751 23
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00949767     History of Changes
Other Study ID Numbers: CN166-001, EUDRACT # is 2009-010220-26
Study First Received: July 29, 2009
Last Updated: January 24, 2011
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014