Skip to main content
OpenTrials
Completed

NCT Number: NCT00892840

Multiple-Ascending Dose Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Uppsala, 751 23, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Panels 1-6: Healthy Male Subjects
  • Panel 7: Females
  • Ages 21 to 55, inclusive
  • Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive
  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion criteria

  • Any major surgery within 4 weeks of study drug administration
  • History of cholecystectomy
  • History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg)
  • Confirmed QTc (Fridericia) value ≥ 450 msec
  • Confirmed QT ≥ 500 msec
  • Confirmed PR ≥ 210 msec
  • Confirmed QRS ≥ 120 msec
  • Confirmed resting supine systolic blood pressure > 140 mmHg
  • Confirmed resting supine diastolic blood pressure > 90 mmHg
  • Confirmed resting heart rate < 45 bpm or > 100 bpm
  • Orthostatic vital sign changes (ie., a decrease in systolic blood pressure from supine to standing > 40 mmHg and an increase in heart rate from supine to standing > 20 bpm) or symptoms of orthostasis
  • History of peppermint allergies
  • Exposure to any investigational drug or placebo within 12 weeks of study drug administration

Treatment and study plan

BMS-820836

Drug

Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days

Placebo

Drug

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

Primary outcomes

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

    Time frame: Within 27 days (+/- 2 days) of first dose

Secondary outcomes

  1. To assess the pharmacodynamics of BMS-820836

    Time frame: Within 27 days of first dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 5, 2009
Registry last updated
Feb 11, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.