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Comparability DE vs CD-CHO1

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: January 12, 2006
Last updated: April 11, 2011
Last verified: April 2011
Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS-188667 in Healthy Subjects

Condition Intervention Phase
Healthy Subjects Drug: Abatacept Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS188667 in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To test pharmacokinetics

Secondary Outcome Measures:
  • To test Safety and immunogenicity

Estimated Enrollment: 30
Study Start Date: September 2002
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00277199

United Kingdom
Inveresk Clinical Research
Edinburgh, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information: Identifier: NCT00277199     History of Changes
Other Study ID Numbers: IM101-017
Study First Received: January 12, 2006
Last Updated: April 11, 2011

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on September 21, 2017