Safety and Pharmacology Study of BMS-866949
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-866949 in Healthy Subjects
2 other identifiers
interventional
47
1 country
1
Brief Summary
The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2010
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
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 13, 2010
CompletedFirst Posted
Study publicly available on registry
May 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedMarch 27, 2012
March 1, 2012
1.5 years
May 13, 2010
March 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of safety by evaluating incidence of adverse events (AE)
Over a period of 28 days (+/- 2 days) of first dose
Secondary Outcomes (2)
Assessment of pharmacokinetics by evaluating plasma concentration versus time data
Over a period 28 days (+/- 2 days) of first dose
Assessment of pharmacodynamics by evaluating brain transporter occupancy
Over a period 28 days (+/- 2 days) of first dose
Study Arms (7)
Placebo or BMS-866949 (3 mg)
ACTIVE COMPARATORPanel 1: Healthy Male Subjects
Placebo or BMS-866949 (10 mg)
ACTIVE COMPARATORPanel 2: Healthy Male Subjects
Placebo or BMS-866949 (30 mg)
ACTIVE COMPARATORPanel 3: Healthy Male Subjects
Placebo or BMS-866949 (45 mg)
ACTIVE COMPARATORPanel 4: Healthy Male Subjects
Placebo or BMS-866949 (60 mg)
ACTIVE COMPARATORPanel 5: Healthy Male Subjects
Placebo or BMS-866949 (90 mg)
ACTIVE COMPARATORPanel 6: Healthy Male Subjects
Placebo or BMS-866949 (3 - 60 mg)
ACTIVE COMPARATORPanel 7: Females
Interventions
Oral Solution, Oral, 0 mg, Once Daily, 14 days
Eligibility Criteria
You may qualify if:
- Panels 1-6: Healthy Male Subjects
- Panel 7: Females
- Ages 21 to 55, inclusive
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
You may not qualify if:
- History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP \<21 mmHg)
- History or family history of psychiatric disorder
- Current treatment with prescription medication
- Exposure to any investigational drug or placebo within 12 weeks of study drug administration
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 Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2010
First Posted
May 17, 2010
Study Start
May 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
March 27, 2012
Record last verified: 2012-03