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

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
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 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
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 30, 2014