Japanese Phase 1 Multiple Ascending Dose (MAD) Study

Bristol-Myers Squibb57 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Depression

Interventions

BMS-820836DRUG

Tablets, Oral, 0.5 mg, Once daily, 14 days

BMS-820836DRUG

Tablets, Oral, 1 mg, Once daily, 14 days

BMS-820836DRUG

Tablets, Oral, 2 mg, Once daily, 14 days

Placebo matching BMS-820836

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Local Institution

Taito-Ku, Tokyo, Japan

Outcomes

Primary Outcomes

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

Secondary Outcomes

Multiple-dose pharmacokinetics parameter Maximum observed concentration (Cmax) of BMS-820836 and BMS-821007