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

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
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: 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
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 21, 2014