Japanese Phase 1 Multiple Ascending Dose (MAD) Study

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396252
• Other study ID #: CN162-014
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2011
• Last updated: June 7, 2013
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• BMS-820836
Tablets, Oral, 0.5 mg, Once daily, 14 days
• BMS-820836
Tablets, Oral, 1 mg, Once daily, 14 days
• BMS-820836
Tablets, Oral, 2 mg, Once daily, 14 days
• Placebo matching BMS-820836
Tablets, Oral, 0 mg, Once daily, 14 days
• BMS-820836
Tablets, Oral, (initiated at 1 mg and dose escalated to the target dose of 2 mg), Once daily, 14 days

Locations

Country	Name	City	State
Japan	Local Institution	Taito-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Multiple-dose pharmacokinetics parameter Maximum observed concentration (Cmax) of BMS-820836 and BMS-821007		Day1 through Day 33	No
Secondary	Multiple-dose pharmacokinetics parameter Concentration at 24 h (C24) of BMS-820836 and BMS-821007		Day1 through Day 33	No
Secondary	Multiple-dose pharmacokinetics parameter Time of maximum observed concentration (Tmax) of BMS-820836 and BMS-821007		Day1 through Day 33	No
Secondary	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	No
Secondary	Multiple-dose pharmacokinetics parameter Apparent total body clearance (CLT/F) of BMS-820836 and BMS-821007		Day1 through Day 33	No
Secondary	Multiple-dose pharmacokinetics parameter accumulation index (AI) of BMS-820836 and BMS-821007		Day1 through Day 33	No
Secondary	Multiple-dose pharmacokinetics parameter half-life (T-HALF) of BMS-820836 and BMS-821007		Day1 through Day 33	No
Secondary	Multiple-dose pharmacokinetics parameter Molar ratio of metabolite to parent Cmax or AUC(TAU)		Day1 through Day 33	No
Secondary	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	Yes
Secondary	Vital sign measures (heart rate and blood pressure) and the orthostatic changes		Day1 through Day 33	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form