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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00949767
First Posted: July 30, 2009
Last Update Posted: January 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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
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

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 ]

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 ]

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

Information from the National Library of Medicine

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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.)
  Contacts and Locations
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
  More Information

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 Submitted: July 29, 2009
First Posted: July 30, 2009
Last Update Posted: January 25, 2011
Last Verified: March 2010