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”

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 (MTC); - 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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• Drug: hyaluronidase (human recombinant) and ceftriaxone
  • Single subcutaneous dose: 150 U hyaluronidase (human recombinant) immediately prior to 1 gm ceftriaxone
• Drug: placebo and ceftriaxone
  • Single subcutaneous dose: saline immediately prior to 1 gm ceftriaxone
• Drug: ceftriaxone
  • single intravenous dose: 1 gm ceftriaxone

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2
• Active Comparator: 3

Primary Measures

• Comparison of the pharmacokinetic parameters for ceftriaxone after subcutaneous administration, with and without HYLENEX recombinant, and after IV administration
  • Time Frame: 48 hours
    Safety Issue?: No
• Safety and tolerability (injection site reactions, adverse events, physical examinations, vital signs) of subcutaneous administration of ceftriaxone, with and without HYLENEX recombinant
  • Time Frame: 7 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Baxter Healthcare Corporation

Overall Clinical Trial Officials and Contacts

George E Harb, MD Study Director Baxter Healthcare Corporation  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00493220

Study ID Number: 1838-004

ClinicalTrials.gov Identifier: NCT00493220

Health Authority: United States: Food and Drug Administration