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

Depression Clinical Trial

Official title:

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949767
• Other study ID #: CN166-001
• Secondary ID: EUDRACT # is 200
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2009
• Last updated: January 24, 2011
• Start date: July 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• BMS-866949
(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
• BMS-866949
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
• BMS-866949
(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
• BMS-866949
(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
• BMS-866949
(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
• BMS-866949
(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
• BMS-866949
(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
• Placebo
(Matching volume) - Oral Solution, Oral, once 14 days

Locations

Country	Name	City	State
Sweden	Local Institution	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs		up to Day 14 +/- 2 days post-dose	Yes
Secondary	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	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form