NCT01396252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1 depression

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

Enrollment Period

8 months

First QC Date

July 15, 2011

Last Update Submit

June 7, 2013

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Arm1: BMS-820836

EXPERIMENTAL

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

Arm 2: Placebo matching BMS-820836

PLACEBO COMPARATOR

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

Interventions

BMS-820836DRUG

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

Arm1: BMS-820836
Placebo matching BMS-820836DRUG

Tablets, Oral, 0 mg, Once daily, 14 days

Arm 2: Placebo matching BMS-820836

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Japanese subjects and Japanese patients with depression (Hamilton Rating Scale for Depression (HAM-D) ≥ 14), ages 20 to 55 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Taito-Ku, Tokyo, 1110052, Japan

Location

Related Links

MeSH Terms

Conditions

Depression

Interventions

6-(2-methyl-4-(2-naphthyl)-1,2,3,4-tetrahydroisoquinolin-7-yl)pyridazin-3-amine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2011

First Posted

July 18, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

JP(1)