Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration (INFUSE-Cftrx)
October 24, 2011 updated by: Baxter Healthcare Corporation
INcreased Flow Utilizing Subcutaneously-Enabled Ceftriaxone (INFUSE-Ceftriaxone) Study: A Phase I Study Comparing the Safety and Pharmacokinetics of Ceftriaxone Administered Subcutaneously With and Without Human Recombinant Hyaluronidase (HYLENEX Recombinant) and Intravenously in Human Volunteers
The objectives of this study are:
- to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration;
- and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, 18-65 years of age
- If female: non-lactating; non-pregnant; and incapable of becoming pregnant, or taking specific precautions to avoid becoming pregnant before and during study
- Normal clinical laboratory parameters
- Adequate venous access in both upper extremities
- Agreeing to refrain from smoking and from ingesting any alcohol or caffeine-containing products before and during the study
- Good health based on medical history, physical examination and laboratory tests
- Non-smoking; or smoking less than 10 cigarettes per day and willing to refrain from use of nicotine products before and during study
Exclusion Criteria:
- Received a cephalosporin within the 21 days prior to study or anticipated to receive non-study cephalosporin during study
- Pregnant or breast-feeding.
- Previously exposed to a hyaluronidase drug product
- Medical condition presenting unacceptable safety risk or likely to prevent completion of study
- Known hypersensitivity to hyaluronidase or any other ingredient in HYLENEX recombinant
- Contraindication to ceftriaxone, including known allergy to beta-lactam antibiotics
- Local condition precluding subcutaneous injection or injection site evaluation
- History of gastrointestinal disease (in particular colitis)
- Consumption of caffeine- or other methylxanthine-containing beverage within 24 hours before and/or during the PK sampling period
- Participation in study of any investigational drug or device within 30 days before this study
- Serum hemoglobin <12 g/dL.
- Blood donation or significant loss of blood within 56 days, or plasma donation within 7 days, prior to study
- Medical history/condition, screening physical examination finding or clinical laboratory result precluding safe participation in study, or which might adversely effect interpretation of study results
- History of drug or alcohol abuse within 2 years prior to study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HYLENEX SC, Placebo SC, IV
subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention
|
single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Names:
|
|
Experimental: HYLENEX SC, IV, Placebo SC
subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention
|
single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Names:
|
|
Experimental: Placebo SC, HYLENEX SC, IV
subcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention
|
single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Names:
|
|
Experimental: Placebo SC, IV, HYLENEX SC
subcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention
|
single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Names:
|
|
Experimental: IV, HYLENEX SC, Placebo SC
IV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention
|
single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Names:
|
|
Experimental: IV, Placebo SC, HYLENEX SC
IV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention
|
single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)
Other Names:
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AUC0-t
Time Frame: Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration
|
Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)
|
Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration
|
|
AUC0-inf
Time Frame: from the start of ceftriaxone administration to infinity
|
Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)
|
from the start of ceftriaxone administration to infinity
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cmax
Time Frame: at the time of the highest measured plasma ceftriaxone concentration
|
Maximum measured plasma ceftriaxone concentration
|
at the time of the highest measured plasma ceftriaxone concentration
|
|
Tmax
Time Frame: from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration
|
Time to maximum measured plasma ceftriaxone concentration
|
from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: George E Harb, MD, Baxter Healthcare Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
June 26, 2007
First Submitted That Met QC Criteria
June 27, 2007
First Posted (Estimate)
June 28, 2007
Study Record Updates
Last Update Posted (Estimate)
December 2, 2011
Last Update Submitted That Met QC Criteria
October 24, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1838-004
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