Clinical trial NCT01439204: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-09-23
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects

Detailed description: Primary Purpose of this study is to compare the pharmacokinetic (PK) of Abatacept (BMS-188667) manufactured at Lonza relative to Abatacept (BMS-188667) manufactured at Devens, MA facility following a single intravenous infusion of 750 mg in healthy subjects

Eligibility 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

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population
timeFrame: Days 1 to 71
measure: Time to Reach Maximum Concentration (Tmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population
timeFrame: Day 1 to Day 71
measure: Area Under the Concentration-time Curve (AUC) From Time Zero to 28 Days [AUC(0-28 Days)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population
timeFrame: Day 1 to Day 71
measure: 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
timeFrame: Day 1 to Day 71
measure: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(0 - INF)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population
timeFrame: Day 1 to Day 71
measure: Terminal Phase Elimination Half-life (T-HALF) of Single Dose Abatacept - Pharmacokinetic Evaluable Population
timeFrame: Day 1 to Day 71
measure: Total Body Clearance (CLT) of Single Dose Abatacept - Pharmacokinetic Evaluable Population
timeFrame: Day 1 to Day 71
measure: Volume of Distribution at Steady-state (Vss) of Single Dose Abatacept - Pharmacokinetic Evaluable Population
timeFrame: Day 1 to Day 71
Secondary outcomes:
measure: Number of Participants With Positive Abatacept-induced Immunogenicity Response
timeFrame: Days 29, 57, 71
measure: Number of Participants With Marked Serum Chemistry Abnormalities on Days 2, 15, 29, 57 and 71 - Safety Population
timeFrame: Day 2 to Day 71
measure: Number of Participants With Marked Hematology Abnormalities on Days 2, 15, 29, 57, and 71 - Safety Population
timeFrame: Day 2 to Day 72
measure: Change From Baseline in Systolic Blood Pressure - Safety Population
timeFrame: Day 1 to Day 71
measure: Change From Baseline in Diastolic Blood Pressure on Days 1, 2, 15, 29, 57, and 71 - Safety Population
timeFrame: Day 1 to Day 71
measure: Number of Participants With a Change From Baseline in QT Interval and Corrected (Fridericia) QT Interval (QTcF) - Safety Population
timeFrame: Day 1 to Day 71
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Icon Clinical Pharmacology Unit, Llc
state: Nebraska
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: