Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects
January 24, 2011 updated by: Bristol-Myers Squibb
Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Uppsala, Sweden, 751 23
- Local Institution
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BMS-866949 (Panel 1)
|
(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
(Matching volume) - Oral Solution, Oral, once 14 days
|
|
Experimental: BMS-866949 (Panel 2)
|
(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
(Matching volume) - Oral Solution, Oral, once 14 days
|
|
Experimental: BMS-866949 (Panel 3)
|
(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
(Matching volume) - Oral Solution, Oral, once 14 days
|
|
Experimental: BMS-866949 (Panel 4)
|
(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
(Matching volume) - Oral Solution, Oral, once 14 days
|
|
Experimental: BMS-866949 (Panel 5)
|
(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
(Matching volume) - Oral Solution, Oral, once 14 days
|
|
Experimental: BMS-866949 (Panel 6)
|
(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
(Matching volume) - Oral Solution, Oral, once 14 days
|
|
Experimental: BMS-866949 (Panel 7)
|
(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days
(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days
(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days
(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days
(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days
(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days
(Matching volume) - Oral Solution, Oral, once 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
up to Day 14 +/- 2 days post-dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Blood samples will be taken up to 144 hour post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
July 29, 2009
First Submitted That Met QC Criteria
July 29, 2009
First Posted (Estimate)
July 30, 2009
Study Record Updates
Last Update Posted (Estimate)
January 25, 2011
Last Update Submitted That Met QC Criteria
January 24, 2011
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CN166-001
- EUDRACT # is 2009-010220-26
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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