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Multiple-Ascending Dose Study

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ClinicalTrials.gov Identifier: NCT00892840
Recruitment Status : Completed
First Posted : May 5, 2009
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine the safety and tolerability of BMS-820836 after multiple doses

Condition or disease Intervention/treatment Phase
Depression Drug: BMS-820836 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-820836 in Healthy Subjects
Study Start Date : May 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Panels 1 to 7 (BMS-820836 or Placebo) Drug: BMS-820836
Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days
Drug: Placebo
Oral Solution, Oral, 0 mg, Once daily, 14 days



Primary Outcome Measures :
  1. To assess the safety and tolerability of BMS-820836 following multiple-dose administration [ Time Frame: Within 27 days (+/- 2 days) of first dose ]

Secondary Outcome Measures :
  1. To assess the pharmacodynamics of BMS-820836 [ Time Frame: Within 27 days of first dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892840


Locations
Sweden
Local Institution
Uppsala, Sweden, 751 23
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00892840     History of Changes
Other Study ID Numbers: CN162-002
2008-008488-86
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011