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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01439204
Date of registration: 21/09/2011
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb
Scientific title: A Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, New Hampshire (NH) in Healthy Subjects
Date of first enrolment: October 2011
Target sample size: 223
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01439204
Study type:  Interventional
Study design:   
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy subjects as determined by no clinically significant deviation from normal in
medical history, physical examination, electrocardiograms (ECGs), and clinical
laboratory determinations

- Body weight will be between 60 and 100 kg, inclusive

Exclusion Criteria:

- Any significant acute or chronic medical illness

- Any major surgery within 4 weeks of study drug administration

- Smoking more than 10 cigarettes per day

- Recent (within 6 months of study drug administration) drug or alcohol abuse.

- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human
Immunodeficiency Virus-1, Human Immunodeficiency Virus-2 antibody

- History of any significant drug allergy or asthma

- Women who are pregnant or breastfeeding and/or unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Biological: Abatacept (BMS-188667)
Primary Outcome(s)
Area Under the Concentration-time Curve (AUC) From Time Zero to 28 Days [AUC(0-28 Days)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population [Time Frame: Day 1 to Day 71]
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(0 - INF)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population [Time Frame: Day 1 to Day 71]
Area Under the Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration [AUC(0-T)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population [Time Frame: Day 1 to Day 71]
Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population [Time Frame: Days 1 to 71]
Terminal Phase Elimination Half-life (T-HALF) of Single Dose Abatacept - Pharmacokinetic Evaluable Population [Time Frame: Day 1 to Day 71]
Time to Reach Maximum Concentration (Tmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population [Time Frame: Day 1 to Day 71]
Total Body Clearance (CLT) of Single Dose Abatacept - Pharmacokinetic Evaluable Population [Time Frame: Day 1 to Day 71]
Volume of Distribution at Steady-state (Vss) of Single Dose Abatacept - Pharmacokinetic Evaluable Population [Time Frame: Day 1 to Day 71]
Secondary Outcome(s)
Change From Baseline in Diastolic Blood Pressure on Days 1, 2, 15, 29, 57, and 71 - Safety Population [Time Frame: Day 1 to Day 71]
Change From Baseline in Systolic Blood Pressure - Safety Population [Time Frame: Day 1 to Day 71]
Number of Participants With a Change From Baseline in QT Interval and Corrected (Fridericia) QT Interval (QTcF) - Safety Population [Time Frame: Day 1 to Day 71]
Number of Participants With Marked Hematology Abnormalities on Days 2, 15, 29, 57, and 71 - Safety Population [Time Frame: Day 2 to Day 72]
Number of Participants With Marked Serum Chemistry Abnormalities on Days 2, 15, 29, 57 and 71 - Safety Population [Time Frame: Day 2 to Day 71]
Number of Participants With Positive Abatacept-induced Immunogenicity Response [Time Frame: Days 29, 57, 71]
Secondary ID(s)
IM101-292
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 04/02/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01439204
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