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CompletedNCT00964912Updated Jan 25, 2011

Single Dose Study of BMS-820836

A Phase 1 interventional study of BMS-820836 and BMS-820836 in Depression, sponsored by Bristol-Myers Squibb. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-25.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Depression

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03

In context

Depression

8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 68 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • Confirmed resting supine systolic blood pressure > 130 mmHg
  • Confirmed resting supine diastolic blood pressure > 80 mmHg
  • Confirmed QT value ≥ 500 msec
  • Confirmed QTc (Bazett) value ≥ 450 msec
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
  • History of peppermint allergies
  • History of brain conditions (e.g. history of stroke, head trauma, etc.)
  • History of or current psychiatric conditions
  • History of claustrophobia
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
68 participants (actual)

Study arms

  • Active comparator
    BMS-820836 (Part 1, Panel 1)

    Drug: BMS-820836 · Drug: Placebo

  • Active comparator
    BMS-820836 (Part 1, Panel 2)

    Drug: BMS-820836 · Drug: Placebo

  • Active comparator
    BMS-820836 (Part 1, Panel 3)

    Drug: BMS-820836 · Drug: Placebo

  • Active comparator
    BMS-820836 (Part 1, Panel 4)

    Drug: BMS-820836 · Drug: Placebo

  • Active comparator
    BMS-820836 (Part 1, Panel 5)

    Drug: BMS-820836 · Drug: Placebo

  • Active comparator
    BMS-820836 (Part 1, Panel 6)

    Drug: BMS-820836 · Drug: Placebo

  • Active comparator
    BMS-820836 (Part 1, Panel 7)

    Drug: BMS-820836 · Drug: Placebo

  • Active comparator
    BMS-820836 (Part 1, Panel 8)

    Drug: BMS-820836 · Drug: Placebo

  • Active comparator
    BMS-820836 (Part 1, Panel 9)

    Drug: BMS-820836 · Drug: Placebo

  • Active comparator
    BMS-820836 (Part 2, Panel A)

    Drug: BMS-820836

  • Active comparator
    BMS-820836 (Part 2, Panel B)

    Drug: BMS-820836

Interventions

  • DrugBMS-820836

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

  • DrugBMS-820836

    Oral Solution, Oral, 0.1 mg, single dose, one dose

  • DrugBMS-820836

    Oral Solution, Oral, 0.25 mg, single dose, one dose

  • DrugBMS-820836

    Oral Solution, Oral, 0.5 mg, single dose, one dose

  • DrugBMS-820836

    Oral Solution, Oral, 1 mg, single dose, one dose

  • DrugBMS-820836

    Oral Solution, Oral, 2 mg, single dose, one dose

  • DrugBMS-820836

    Oral Solution, Oral, 3 mg, single dose, one dose

  • DrugBMS-820836

    Oral Solution, Oral, 5 mg, single dose, one dose

  • DrugBMS-820836

    Oral Solution, Oral, 8 mg, single dose, one dose

  • DrugPlacebo

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

  • DrugBMS-820836

    Oral Solution, Oral, 3 mg, single dose, one dose

  • DrugBMS-820836

    Oral Solution, Oral, 0.5 mg, single dose, one dose

06

What researchers measure

Primary outcomes

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

    Time frame: Within 14 days of first dose

Secondary outcomes

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

    Time frame: Within 7 days of dosing

  2. To assess the pharmacodynamics of BMS-820836

    Time frame: Within 48 hours of dosing

07

Study locations

1 site
  • Local Institution
    Toronto, Ontario M5V 2T3, Canada
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00964912
Lead sponsor
Bristol-Myers Squibb
First posted
Aug 25, 2009
Start date
Jul 2008
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Jan 25, 2011

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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