Single Dose Study of BMS-820836

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00964912
First received: August 24, 2009
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to determine the safety and tolerability of BMS-820836 after single 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 Single-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 single-dose administration [ Time Frame: Within 14 days of first dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007 [ Time Frame: Within 7 days of dosing ] [ Designated as safety issue: No ]
  • To assess the pharmacodynamics of BMS-820836 [ Time Frame: Within 48 hours of dosing ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BMS-820836 (Part 1, Panel 1) Drug: BMS-820836
Oral Solution, Oral, 0.025 mg, single dose, one dose
Drug: Placebo
Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 2) Drug: BMS-820836
Oral Solution, Oral, 0.1 mg, single dose, one dose
Drug: Placebo
Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 3) Drug: BMS-820836
Oral Solution, Oral, 0.25 mg, single dose, one dose
Drug: Placebo
Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 4) Drug: BMS-820836
Oral Solution, Oral, 0.5 mg, single dose, one dose
Drug: Placebo
Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 5) Drug: BMS-820836
Oral Solution, Oral, 1 mg, single dose, one dose
Drug: Placebo
Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 6) Drug: BMS-820836
Oral Solution, Oral, 2 mg, single dose, one dose
Drug: Placebo
Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 7) Drug: BMS-820836
Oral Solution, Oral, 3 mg, single dose, one dose
Drug: Placebo
Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 8) Drug: BMS-820836
Oral Solution, Oral, 5 mg, single dose, one dose
Drug: Placebo
Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 1, Panel 9) Drug: BMS-820836
Oral Solution, Oral, 8 mg, single dose, one dose
Drug: Placebo
Oral Solution, Oral, 0 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 2, Panel A) Drug: BMS-820836
Oral Solution, Oral, 3 mg, single dose, one dose
Active Comparator: BMS-820836 (Part 2, Panel B) Drug: BMS-820836
Oral Solution, Oral, 0.5 mg, single dose, one dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg
  • Right-handed, non-ambidextrous subjects for Part 2
  • Men and women, ages 18 to 55 years, inclusive

Exclusion Criteria:

  • Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
  • WOCBP using a prohibited contraceptive method
  • Women who are pregnant or breastfeeding
  • Sexually active fertile men not using effective birth control if their partners are WOCBP
  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months) gastrointestinal disease
  • History of cholecystectomy
  • Any major surgery within 4 weeks of study drug administration
  • Any gastrointestinal surgery that could impact the absorption of study drug
  • Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration
  • Blood transfusion within 4 weeks of study drug administration
  • Inability to tolerate/swallow oral medication
  • Difficulty with venipuncture and/or poor venous access
  • Self-reported smokers
  • Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy)
  • Confirmed resting supine systolic blood pressure > 130 mmHg
  • Confirmed resting supine diastolic blood pressure > 80 mmHg
  • Confirmed QT value ≥ 500 msec
  • Confirmed QTc (Bazett) value ≥ 450 msec
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
  • History of peppermint allergies
  • History of brain conditions (e.g. history of stroke, head trauma, etc.)
  • History of or current psychiatric conditions
  • History of claustrophobia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964912

Locations
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5V 2T3
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: NCT00964912     History of Changes
Other Study ID Numbers: CN162-001
Study First Received: August 24, 2009
Last Updated: January 24, 2011
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on April 16, 2014