NCT00277199

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
Last Updated

April 13, 2011

Status Verified

April 1, 2011

Enrollment Period

3 months

First QC Date

January 12, 2006

Last Update Submit

April 11, 2011

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • To test pharmacokinetics

Secondary Outcomes (1)

  • To test Safety and immunogenicity

Interventions

AbataceptDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inveresk Clinical Research

Edinburgh, United Kingdom

Location

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 16, 2006

Study Start

September 1, 2002

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

April 13, 2011

Record last verified: 2011-04

Locations

GB(1)