Clinical trial NCT01396252: Japanese Phase 1 Multiple Ascending Dose (MAD) Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Day 1 through Day 33
Secondary outcomes:
measure: Multiple-dose pharmacokinetics parameter Maximum observed concentration (Cmax) of BMS-820836 and BMS-821007
timeFrame: Day1 through Day 33
measure: Multiple-dose pharmacokinetics parameter Concentration at 24 h (C24) of BMS-820836 and BMS-821007
timeFrame: Day1 through Day 33
measure: Multiple-dose pharmacokinetics parameter Time of maximum observed concentration (Tmax) of BMS-820836 and BMS-821007
timeFrame: Day1 through Day 33
measure: Multiple-dose pharmacokinetics parameter Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-820836 and BMS-821007
timeFrame: Day1 through Day 33
measure: Multiple-dose pharmacokinetics parameter Apparent total body clearance (CLT/F) of BMS-820836 and BMS-821007
timeFrame: Day1 through Day 33
measure: Multiple-dose pharmacokinetics parameter accumulation index (AI) of BMS-820836 and BMS-821007
timeFrame: Day1 through Day 33
measure: Multiple-dose pharmacokinetics parameter half-life (T-HALF) of BMS-820836 and BMS-821007
timeFrame: Day1 through Day 33
measure: Multiple-dose pharmacokinetics parameter Molar ratio of metabolite to parent Cmax or AUC(TAU)
timeFrame: Day1 through Day 33
measure: ECG parameters (heart rate, PR, QRS, QT, and QTcF intervals)
timeFrame: Day1 through Day 33
measure: Vital sign measures (heart rate and blood pressure) and the orthostatic changes
timeFrame: Day1 through Day 33
Other outcomes:
Locations:
city: Taito-Ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: