Japanese Phase 1 Multiple Ascending Dose (MAD) Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01396252
First received: July 15, 2011
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled, Double-Blind, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-820836 in Healthy Japanese Subjects and Japanese Patients With Depression

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety and tolerability based on medical review of adverse events & results of vital sign measurements, electrocardiogram (ECGs), physical examinations, clinical laboratory test, suicidality evaluation & Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Day 1 through Day 33 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Multiple-dose pharmacokinetics parameter Maximum observed concentration (Cmax) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
  • Multiple-dose pharmacokinetics parameter Concentration at 24 h (C24) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
  • Multiple-dose pharmacokinetics parameter Time of maximum observed concentration (Tmax) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
  • Multiple-dose pharmacokinetics parameter Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
  • Multiple-dose pharmacokinetics parameter Apparent total body clearance (CLT/F) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
  • Multiple-dose pharmacokinetics parameter accumulation index (AI) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
  • Multiple-dose pharmacokinetics parameter half-life (T-HALF) of BMS-820836 and BMS-821007 [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
  • Multiple-dose pharmacokinetics parameter Molar ratio of metabolite to parent Cmax or AUC(TAU) [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: No ]
  • ECG parameters (heart rate, PR, QRS, QT, and QTcF intervals) [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: Yes ]
    QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula

  • Vital sign measures (heart rate and blood pressure) and the orthostatic changes [ Time Frame: Day1 through Day 33 ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm1: BMS-820836
Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)
Drug: BMS-820836
Tablets, Oral, 0.5 mg, Once daily, 14 days
Drug: BMS-820836
Tablets, Oral, 1 mg, Once daily, 14 days
Drug: BMS-820836
Tablets, Oral, 2 mg, Once daily, 14 days
Drug: BMS-820836
Tablets, Oral, (initiated at 1 mg and dose escalated to the target dose of 2 mg), Once daily, 14 days
Placebo Comparator: Arm 2: Placebo matching BMS-820836
Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)
Drug: Placebo matching BMS-820836
Tablets, Oral, 0 mg, Once daily, 14 days

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese subjects and Japanese patients with depression (Hamilton Rating Scale for Depression (HAM-D) ≥ 14), ages 20 to 55 years.

Exclusion Criteria:

  • Any significant acute or chronic medical illness.
  • Non-compliance, or overall not suitable as determined by the investigator.
  • History of, or current clinically significant psychiatric disorders or illnesses, substance abuse or dependence.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396252

Locations
Japan
Local Institution
Taito-Ku, Tokyo, Japan, 1110052
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01396252     History of Changes
Other Study ID Numbers: CN162-014
Study First Received: July 15, 2011
Last Updated: June 7, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on April 17, 2014