Comparability DE vs CD-CHO1

April 11, 2011 updated by: Bristol-Myers Squibb

Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS188667 in Healthy Subjects

Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS-188667 in Healthy Subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

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

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed consent form
  • Healthy subjects as determined by good health as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations.
  • Body weight for all subjects will be <- 100 kg.
  • body Mass Index (BMI) of 18-30 kg/m2 inclusive; BMI = weight (kg)/[height (m)]2
  • Men and women (not nursing, not prgnant), who are at least 18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study for at least 4 weeks before and for up to 10 weeks after the infusion of BMS-188667 in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

  • WOCBP and males who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 10 weeks after he infusion of BMS-1886678. WOCBP must also be using an acceptable method of contraception for at least 1 month before dosing.
  • Women who are pregnant ore breast-feeding.
  • Women with positive pregnanacy tes on enrollment or prior to study drug administration.
  • History or current evidence of any signiicant acute or chroinic medical illness

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To test pharmacokinetics

Secondary Outcome Measures

Outcome Measure
To test Safety and immunogenicity

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

September 1, 2002

Primary Completion (ACTUAL)

December 1, 2002

Study Completion (ACTUAL)

December 1, 2002

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (ESTIMATE)

January 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 13, 2011

Last Update Submitted That Met QC Criteria

April 11, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-017
  • 016149

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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