Multiple-Ascending Dose Study
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-820836 in Healthy Subjects
2 other identifiers
interventional
57
1 country
1
Brief Summary
The purpose of this study is to determine the safety and tolerability of BMS-820836 after multiple doses
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 May 2009
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, 2009
CompletedFirst Submitted
Initial submission to the registry
May 2, 2009
CompletedFirst Posted
Study publicly available on registry
May 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFebruary 11, 2011
February 1, 2011
1.5 years
May 2, 2009
February 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of BMS-820836 following multiple-dose administration
Within 27 days (+/- 2 days) of first dose
Secondary Outcomes (1)
To assess the pharmacodynamics of BMS-820836
Within 27 days of first dose
Study Arms (1)
Panels 1 to 7 (BMS-820836 or Placebo)
EXPERIMENTALInterventions
Oral Solution, Oral, 0.1 mg to 4 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:
- Any major surgery within 4 weeks of study drug administration
- History of cholecystectomy
- History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP \<21 mmHg)
- Confirmed QTc (Fridericia) value ≥ 450 msec
- Confirmed QT ≥ 500 msec
- Confirmed PR ≥ 210 msec
- Confirmed QRS ≥ 120 msec
- Confirmed resting supine systolic blood pressure \> 140 mmHg
- Confirmed resting supine diastolic blood pressure \> 90 mmHg
- Confirmed resting heart rate \< 45 bpm or \> 100 bpm
- Orthostatic vital sign changes (ie., a decrease in systolic blood pressure from supine to standing \> 40 mmHg and an increase in heart rate from supine to standing \> 20 bpm) or symptoms of orthostasis
- History of peppermint allergies
- 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
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2009
First Posted
May 5, 2009
Study Start
May 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
February 11, 2011
Record last verified: 2011-02