Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects

February 22, 2011 updated by: Bristol-Myers Squibb

Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects

The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 in healthy subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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

  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • 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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women (not of child bearing potential) ages 18 to 45
  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

  • Women of child bearing potential
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BMS-779788 or Placebo (Arm 1)
Drug: BMS-779788
Oral Solution, Oral, 1 mg, Once daily, 7 days
Drug: BMS-779788
Oral Solution, Oral, 2 mg, Once daily, 7 days
Drug: BMS-779788
Oral Solution, Oral, <= 4 mg, Once daily, 7 days
Drug: Placebo
Oral Solution, Oral, 0 mg, Once daily, 7 days
Active Comparator: BMS-779788 or Placebo (Arm 2)
Drug: BMS-779788
Oral Solution, Oral, 1 mg, Once daily, 7 days
Drug: BMS-779788
Oral Solution, Oral, 2 mg, Once daily, 7 days
Drug: BMS-779788
Oral Solution, Oral, <= 4 mg, Once daily, 7 days
Drug: Placebo
Oral Solution, Oral, 0 mg, Once daily, 7 days
Active Comparator: BMS-779788 or Placebo (Arm 3)
Drug: BMS-779788
Oral Solution, Oral, 1 mg, Once daily, 7 days
Drug: BMS-779788
Oral Solution, Oral, 2 mg, Once daily, 7 days
Drug: BMS-779788
Oral Solution, Oral, <= 4 mg, Once daily, 7 days
Drug: Placebo
Oral Solution, Oral, 0 mg, Once daily, 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Time Frame: 8 times within 27 days of the first dose
8 times within 27 days of the first dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)
Time Frame: After each dose panel
After each dose panel

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

February 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 30, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV197-002

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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