Japanese Phase 1 Multiple Ascending Dose (MAD) Study

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: BMS-820836; Drug: BMS-820836; Drug: BMS-820836; Drug: BMS-820836; Drug: Placebo matching BMS-820836

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Taito-Ku, Tokyo, Japan, 1110052
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	Day 1 through Day 33

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple-dose pharmacokinetics parameter Maximum observed concentration (Cmax) of BMS-820836 and BMS-821007		Day1 through Day 33
Multiple-dose pharmacokinetics parameter Concentration at 24 h (C24) of BMS-820836 and BMS-821007		Day1 through Day 33
Multiple-dose pharmacokinetics parameter Time of maximum observed concentration (Tmax) of BMS-820836 and BMS-821007		Day1 through Day 33
Multiple-dose pharmacokinetics parameter Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-820836 and BMS-821007		Day1 through Day 33
Multiple-dose pharmacokinetics parameter Apparent total body clearance (CLT/F) of BMS-820836 and BMS-821007		Day1 through Day 33
Multiple-dose pharmacokinetics parameter accumulation index (AI) of BMS-820836 and BMS-821007		Day1 through Day 33
Multiple-dose pharmacokinetics parameter half-life (T-HALF) of BMS-820836 and BMS-821007		Day1 through Day 33
Multiple-dose pharmacokinetics parameter Molar ratio of metabolite to parent Cmax or AUC(TAU)		Day1 through Day 33
ECG parameters (heart rate, PR, QRS, QT, and QTcF intervals)	QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula	Day1 through Day 33
Vital sign measures (heart rate and blood pressure) and the orthostatic changes		Day1 through Day 33

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: July 15, 2011
• First Submitted That Met QC Criteria: July 15, 2011
• First Posted (Estimate): July 18, 2011

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: June 7, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: CN162-014