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

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ClinicalTrials.gov Identifier: NCT00949767
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Depression Drug: BMS-866949 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects
Study Start Date : July 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.)

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): NCT00949767


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

Additional Information:
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
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: March 2010