Multiple-Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00892840
First received: May 2, 2009
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the pharmacodynamics of BMS-820836 [ Time Frame: Within 27 days of first dose ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892840

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

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00892840     History of Changes
Other Study ID Numbers: CN162-002, 2008-008488-86
Study First Received: May 2, 2009
Last Updated: February 10, 2011
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 20, 2014