Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
57 participants
INTERVENTIONAL
2009-05-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Panels 1 to 7 (BMS-820836 or Placebo)
BMS-820836
Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days
Placebo
Oral Solution, Oral, 0 mg, Once daily, 14 days
Interventions
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BMS-820836
Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days
Placebo
Oral Solution, Oral, 0 mg, Once daily, 14 days
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
21 Years
55 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Uppsala, , Sweden
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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2008-008488-86
Identifier Type: -
Identifier Source: secondary_id
CN162-002
Identifier Type: -
Identifier Source: org_study_id
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