NCT00242385CompletedPhase 1
Single-Dose, Double-Blind, Crossover Study to Evaluate the Pharmacokinetic Comparability of ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (ARALAST Fr. IV-1) and ARALAST
Baxalta now part of Shire7 sites in 2 countries25 target enrollmentStarted: December 20, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 7
- Primary Endpoint
- Area Under the Curve/Dose
Study Overview
Brief Summary
The primary purpose of this study is to characterize the pharmacokinetic profile of intravenous Aralast Fraction (Fr.) IV-1, a sterile, stable, lyophilized preparation of functionally intact human Alpha1- Proteinase Inhibitor (α1-PI). This pharmacokinetic study will be a randomized controlled clinical trial with a cross-over design. Twenty-four subjects will be enrolled into the study. Overall study duration will be approximately 6-8 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The subject or subject´s legally authorized representative has provided written informed consent
- •Subject is 18 years of age or older
- •Subject has a documented, endogenous plasma Alpha1-PI level < 8 Micromolar
- •Subject is of the genotype Pi*Z/Z, Pi*Z/Null, Pi*Null/Null, Pi*Malton/Z, or others, dependent on the approval by the Sponsor
- •If the subject is female or of childbearing potential, the subject has a negative urine test for pregnancy within 7 days prior to first study product administration and agrees to employ adequate birth control measures for the duration of the study
- •Laboratory results obtained at the screening visit, meeting the following criteria:
- •Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 2 times the upper limit of normal (ULN)
- •Serum total bilirubin <= 2 times ULN
- •Proteinuria < +2 on dipstick analysis
- •Serum creatinine <= 1.5 times ULN
- •Absolute neutrophil count (ANC) >= 1500 cells/mm3
- •Hemoglobin >= 10.0 g/dL
- •Platelet count >= 10^5/mm3
- •If the subject is treated with any respiratory medications, including inhaled bronchodilators and inhaled or oral corticosteroids, the subjects´ medication doses were unchanged for at least 14 days prior to first study product administration
- •Nonsmoker for a minimum of 3 months prior to first study product administration
Exclusion Criteria
- •The subject has received any Alpha1-PI augmentation therapy (including Aralast and investigational Alpha1-PIs, by any route including intravenous and inhaled) within 42 days prior to first study product administration
- •The subject has received an investigational drug or device within 1 month prior to first study product administration, or the subject is currently receiving an investigational drug
- •The subject has a known selective immunoglobulin A (IgA) deficiency (IgA level < 15 mg/dL) and/or antibody to IgA
- •The subject has a pulmonary exacerbation or had a pulmonary exacerbation in the past 14 days prior to first study product administration
- •The subject is pregnant or lactating, or intends to become pregnant during the course of the study
- •The subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
Outcomes
Primary Outcomes
Area Under the Curve/Dose
Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion
Area under the plasma alpha1-proteinase inhibitor (α1-PI) concentration versus time curve (AUC) calculated by linear trapezoidal method per dose.
Secondary Outcomes
- Mean Residence Time (MRT)(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Time to Maximum α1-PI Concentration Post-infusion (Tmax)(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Incremental Recovery(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Systemic Clearance (CL)(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Apparent Volume of Distribution at Steady State(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Adverse Events (AEs)(Throughout study period (7 months))
- Total Area Under the Curve Per Dose(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Terminal Half-life(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
- Maximum Plasma Concentration (Cmax)(Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion)
Investigators
Study Sites (7)
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