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Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration (INFUSE-Cftrx)
This study has been completed.
First Received: June 26, 2007   Last Updated: September 25, 2008   History of Changes
Sponsor: Baxter Healthcare Corporation
Collaborator: Halozyme Therapeutics
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00493220
  Purpose

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.

Condition Intervention Phase
Healthy
Drug: hyaluronidase (human recombinant) and ceftriaxone
Drug: placebo and ceftriaxone
Drug: ceftriaxone
Phase I

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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Comparison of the pharmacokinetic parameters for ceftriaxone after subcutaneous administration, with and without HYLENEX recombinant, and after IV administration [ Time Frame: 48 hours ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: June 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: hyaluronidase (human recombinant) and ceftriaxone
Single subcutaneous dose: 150 U hyaluronidase (human recombinant) immediately prior to 1 gm ceftriaxone
2: Placebo Comparator Drug: placebo and ceftriaxone
Single subcutaneous dose: saline immediately prior to 1 gm ceftriaxone
3: Active Comparator Drug: ceftriaxone
single intravenous dose: 1 gm ceftriaxone

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493220

Sponsors and Collaborators
Baxter Healthcare Corporation
Halozyme Therapeutics
Investigators
Study Director: George E Harb, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation ( Geroge E. Harb, MD )
Study ID Numbers: 1838-004
Study First Received: June 26, 2007
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00493220     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:
ceftriaxone
cephalosporins
pharmacokinetics
subcutaneous
hyaluronoglucosaminidase
hyaluronidase
hyaluronan
rHuPH20

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Ceftriaxone
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010