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Completed

NCT Number: NCT00964912

Single Dose Study of BMS-820836

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Toronto, Ontario, M5V 2T3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

BMS-820836

Drug

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

Placebo

Drug

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

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-820836 in Healthy Subjects

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2009
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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