Phase 1
Completed N=72
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
Source: ClinicalTrials.gov NCT01439204 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population — 262; 255 µg/mL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population |
262; 255 | — |
| PRIMARY Time to Reach Maximum Concentration (Tmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population |
1.00; 1.00 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC) From Time Zero to 28 Days [AUC(0-28 Days)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population |
33195; 35255 | — |
| PRIMARY 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 |
39295; 41916 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(0 - INF)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population |
40385; 43229 | — |
| PRIMARY Terminal Phase Elimination Half-life (T-HALF) of Single Dose Abatacept - Pharmacokinetic Evaluable Population |
344; 364 | — |
| PRIMARY Total Body Clearance (CLT) of Single Dose Abatacept - Pharmacokinetic Evaluable Population |
0.237; 0.219 | — |
| PRIMARY Volume of Distribution at Steady-state (Vss) of Single Dose Abatacept - Pharmacokinetic Evaluable Population |
0.088; 0.083 | — |
| SECONDARY Number of Participants With Positive Abatacept-induced Immunogenicity Response |
4; 1 | — |
| SECONDARY Number of Participants With Marked Serum Chemistry Abnormalities on Days 2, 15, 29, 57 and 71 - Safety Population |
1; 0; 1; 0; 2; 1 | — |
| SECONDARY Number of Participants With Marked Hematology Abnormalities on Days 2, 15, 29, 57, and 71 - Safety Population |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure - Safety Population |
-6.3; -4.5; -3.0; -1.4; -1.1; 0.3 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure on Days 1, 2, 15, 29, 57, and 71 - Safety Population |
-4.9; -4.1; -2.3; -0.6; -1.4; 1.0 | — |
| SECONDARY Number of Participants With a Change From Baseline in QT Interval and Corrected (Fridericia) QT Interval (QTcF) - Safety Population |
0; 1; 5; 4; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01439204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.