Japanese Phase 1 Multiple Ascending Dose (MAD) Study

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: Placebo matching BMS-820836; Drug: BMS-820836

• Registration Number: NCT01396252
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-15
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-18
• Study Start: 2011-09
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-07
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Placebo matching BMS-820836	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)
Arm1: BMS-820836	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)	Day1 through Day 33	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	Day1 through Day 33

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Taito-Ku, Tokyo, Japan