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Multiple-Ascending Dose Study

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: May 2, 2009
Last updated: February 10, 2011
Last verified: February 2011
The purpose of this study is to determine the safety and tolerability of BMS-820836 after multiple doses

Condition Intervention Phase
Depression Drug: BMS-820836 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Further study details as provided by Bristol-Myers Squibb:

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

Enrollment: 57
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00892840

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

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00892840     History of Changes
Other Study ID Numbers: CN162-002
Study First Received: May 2, 2009
Last Updated: February 10, 2011 processed this record on June 22, 2017