Status:
COMPLETED
Multiple-Ascending Dose Study
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Depression
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and tolerability of BMS-820836 after multiple doses
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00892840
Start Date
May 1 2009
End Date
November 1 2010
Last Update
February 11 2011
Active Locations (1)
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1
Local Institution
Uppsala, Sweden, 751 23