Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects
Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects
2 other identifiers
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 depression
Started Jul 2009
Shorter than P25 for phase_1 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJanuary 25, 2011
March 1, 2010
8 months
July 29, 2009
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs
up to Day 14 +/- 2 days post-dose
Secondary Outcomes (1)
Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples
Blood samples will be taken up to 144 hour post-dose
Study Arms (7)
BMS-866949 (Panel 1)
EXPERIMENTALBMS-866949 (Panel 2)
EXPERIMENTALBMS-866949 (Panel 3)
EXPERIMENTALBMS-866949 (Panel 4)
EXPERIMENTALBMS-866949 (Panel 5)
EXPERIMENTALBMS-866949 (Panel 6)
EXPERIMENTALBMS-866949 (Panel 7)
EXPERIMENTALInterventions
(Matching volume) - Oral Solution, Oral, once 14 days
Eligibility Criteria
You may qualify if:
- Healthy male 18-55
- Women not of child bearing potential, 18-55
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Uppsala, 751 23, Sweden
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 29, 2009
First Posted
July 30, 2009
Study Start
July 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
January 25, 2011
Record last verified: 2010-03