NCT00964912

Brief Summary

The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for phase_1 depression

Timeline
Completed

Started Jul 2008

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

Study Start

First participant enrolled

July 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
Last Updated

January 25, 2011

Status Verified

January 1, 2011

Enrollment Period

9 months

First QC Date

August 24, 2009

Last Update Submit

January 24, 2011

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and tolerability of BMS-820836 following single-dose administration

    Within 14 days of first dose

Secondary Outcomes (2)

  • To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007

    Within 7 days of dosing

  • To assess the pharmacodynamics of BMS-820836

    Within 48 hours of dosing

Study Arms (11)

BMS-820836 (Part 1, Panel 1)

ACTIVE COMPARATOR
Drug: BMS-820836Drug: Placebo

BMS-820836 (Part 1, Panel 2)

ACTIVE COMPARATOR
Drug: BMS-820836Drug: Placebo

BMS-820836 (Part 1, Panel 3)

ACTIVE COMPARATOR
Drug: BMS-820836Drug: Placebo

BMS-820836 (Part 1, Panel 4)

ACTIVE COMPARATOR
Drug: BMS-820836Drug: Placebo

BMS-820836 (Part 1, Panel 5)

ACTIVE COMPARATOR
Drug: BMS-820836Drug: Placebo

BMS-820836 (Part 1, Panel 6)

ACTIVE COMPARATOR
Drug: BMS-820836Drug: Placebo

BMS-820836 (Part 1, Panel 7)

ACTIVE COMPARATOR
Drug: BMS-820836Drug: Placebo

BMS-820836 (Part 1, Panel 8)

ACTIVE COMPARATOR
Drug: BMS-820836Drug: Placebo

BMS-820836 (Part 1, Panel 9)

ACTIVE COMPARATOR
Drug: BMS-820836Drug: Placebo

BMS-820836 (Part 2, Panel A)

ACTIVE COMPARATOR
Drug: BMS-820836

BMS-820836 (Part 2, Panel B)

ACTIVE COMPARATOR
Drug: BMS-820836

Interventions

BMS-820836DRUG

Oral Solution, Oral, 0.025 mg, single dose, one dose

BMS-820836 (Part 1, Panel 1)
PlaceboDRUG

Oral Solution, Oral, 0 mg, single dose, one dose

BMS-820836 (Part 1, Panel 1)BMS-820836 (Part 1, Panel 2)BMS-820836 (Part 1, Panel 3)BMS-820836 (Part 1, Panel 4)BMS-820836 (Part 1, Panel 5)BMS-820836 (Part 1, Panel 6)BMS-820836 (Part 1, Panel 7)BMS-820836 (Part 1, Panel 8)BMS-820836 (Part 1, Panel 9)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg
  • Right-handed, non-ambidextrous subjects for Part 2
  • Men and women, ages 18 to 55 years, inclusive

You may not qualify if:

  • Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
  • WOCBP using a prohibited contraceptive method
  • Women who are pregnant or breastfeeding
  • Sexually active fertile men not using effective birth control if their partners are WOCBP
  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months) gastrointestinal disease
  • History of cholecystectomy
  • Any major surgery within 4 weeks of study drug administration
  • Any gastrointestinal surgery that could impact the absorption of study drug
  • Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration
  • Blood transfusion within 4 weeks of study drug administration
  • Inability to tolerate/swallow oral medication
  • Difficulty with venipuncture and/or poor venous access
  • Self-reported smokers
  • Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy)
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Toronto, Ontario, M5V 2T3, Canada

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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

July 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

January 25, 2011

Record last verified: 2011-01

Locations

CA(1)