Comparability DE vs CD-CHO1

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277199
• Other study ID #: IM101-017
• Secondary ID: 016149
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2006
• Last updated: April 11, 2011
• Start date: September 2002
• Est. completion date: December 2002

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: Scottish Executive Health Department
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Abatacept

Locations

Country	Name	City	State
United Kingdom	Inveresk Clinical Research	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test pharmacokinetics
Secondary	To test Safety and immunogenicity

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm