Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects
Phase 1
Completed
- Conditions
- Depression
- Interventions
- Drug: BMS-866949Drug: Placebo
- Registration Number
- NCT00949767
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Healthy male 18-55
- Women not of child bearing potential, 18-55
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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.)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-866949 (Panel 7) Placebo - BMS-866949 (Panel 1) BMS-866949 - BMS-866949 (Panel 1) Placebo - BMS-866949 (Panel 2) BMS-866949 - BMS-866949 (Panel 2) Placebo - BMS-866949 (Panel 3) BMS-866949 - BMS-866949 (Panel 3) Placebo - BMS-866949 (Panel 4) BMS-866949 - BMS-866949 (Panel 4) Placebo - BMS-866949 (Panel 5) BMS-866949 - BMS-866949 (Panel 5) Placebo - BMS-866949 (Panel 6) BMS-866949 - BMS-866949 (Panel 6) Placebo - BMS-866949 (Panel 7) BMS-866949 -
- Primary Outcome Measures
Name Time Method Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs up to Day 14 +/- 2 days post-dose
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Local Institution
🇸🇪Uppsala, Sweden