Comparability DE vs CD-CHO1

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00277199
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Abatacept	Phase 1

Study Design

• Study Type: Interventional
• 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
• Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: Dec 1, 2002
• Actual Study Completion Date: Dec 1, 2002

Outcome Measures

Primary Outcome Measures

1. To test pharmacokinetics []

Secondary Outcome Measures

1. To test Safety and immunogenicity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Inveresk Clinical Research	Edinburgh		United Kingdom

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00277199
• Other Study ID Numbers: IM101-017; 016149
• First Posted: Jan 16, 2006
• Last Update Posted: Apr 13, 2011
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Abatacept

Study Results

No Results Posted as of Apr 13, 2011