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

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
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: 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
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014