Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration
Information source: Baxter Healthcare Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: SC HYLENEX and Ceftriaxone (Drug); SC Placebo and Ceftriaxone (Drug); IV Ceftriaxone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Baxter Healthcare Corporation Official(s) and/or principal investigator(s): George E Harb, MD, Study Director, Affiliation: Baxter Healthcare Corporation
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: AUC0-tAUC0-inf
Secondary outcome: CmaxTmax
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: June 2007
Last updated: October 24, 2011
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