Japanese Phase 1 Multiple Ascending Dose (MAD) Study

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT01396252

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: BMS-820836 Drug: BMS-820836 Drug: BMS-820836 Drug: Placebo matching BMS-820836 Drug: BMS-820836	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Taito-Ku	Tokyo	Japan	1110052

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

BMS clinical trial educational resource

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01396252

Other Study ID Numbers:

CN162-014

First Posted:

Jul 18, 2011

Last Update Posted:

Jun 10, 2013

Last Verified:

Jun 1, 2013

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Jun 10, 2013