Multiple-Ascending Dose Study

February 10, 2011 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 23
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panels 1 to 7 (BMS-820836 or Placebo)
Drug: BMS-820836
Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days
Drug: Placebo
Oral Solution, Oral, 0 mg, Once daily, 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of BMS-820836 following multiple-dose administration
Time Frame: Within 27 days (+/- 2 days) of first dose
Within 27 days (+/- 2 days) of first dose

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the pharmacodynamics of BMS-820836
Time Frame: Within 27 days of first dose
Within 27 days of first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 2, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

February 11, 2011

Last Update Submitted That Met QC Criteria

February 10, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN162-002
  • 2008-008488-86

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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