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Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration (INFUSE-Cftrx)

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ClinicalTrials.gov Identifier: NCT00493220
Recruitment Status : Completed
First Posted : June 28, 2007
Results First Posted : December 2, 2011
Last Update Posted : December 2, 2011
Sponsor:
Collaborator:
Halozyme Therapeutics
Information provided by:
Baxter Healthcare Corporation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: SC HYLENEX and Ceftriaxone Drug: SC Placebo and Ceftriaxone Drug: IV Ceftriaxone Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Drug: SC HYLENEX and Ceftriaxone
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:
  • HYLENEX recombinant
  • hyaluronoglucosaminidase
  • hyaluronidase
  • rHuPH20

Drug: SC Placebo and Ceftriaxone
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:
  • saline
  • normal saline
  • 0.9% sodium chloride injection

Drug: IV Ceftriaxone
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Name: ceftriaxone
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
 Drug: SC HYLENEX and Ceftriaxone
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:
  • HYLENEX recombinant
  • hyaluronoglucosaminidase
  • hyaluronidase
  • rHuPH20

Drug: SC Placebo and Ceftriaxone
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:
  • saline
  • normal saline
  • 0.9% sodium chloride injection

Drug: IV Ceftriaxone
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Name: ceftriaxone
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
 Drug: SC HYLENEX and Ceftriaxone
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:
  • HYLENEX recombinant
  • hyaluronoglucosaminidase
  • hyaluronidase
  • rHuPH20

Drug: SC Placebo and Ceftriaxone
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:
  • saline
  • normal saline
  • 0.9% sodium chloride injection

Drug: IV Ceftriaxone
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Name: ceftriaxone
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
 Drug: SC HYLENEX and Ceftriaxone
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:
  • HYLENEX recombinant
  • hyaluronoglucosaminidase
  • hyaluronidase
  • rHuPH20

Drug: SC Placebo and Ceftriaxone
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:
  • saline
  • normal saline
  • 0.9% sodium chloride injection

Drug: IV Ceftriaxone
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Name: ceftriaxone
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
 Drug: SC HYLENEX and Ceftriaxone
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:
  • HYLENEX recombinant
  • hyaluronoglucosaminidase
  • hyaluronidase
  • rHuPH20

Drug: SC Placebo and Ceftriaxone
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:
  • saline
  • normal saline
  • 0.9% sodium chloride injection

Drug: IV Ceftriaxone
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Name: ceftriaxone
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
 Drug: SC HYLENEX and Ceftriaxone
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:
  • HYLENEX recombinant
  • hyaluronoglucosaminidase
  • hyaluronidase
  • rHuPH20

Drug: SC Placebo and Ceftriaxone
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:
  • saline
  • normal saline
  • 0.9% sodium chloride injection

Drug: IV Ceftriaxone
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
Other Name: ceftriaxone


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. Cmax [ Time Frame: at the time of the highest measured plasma ceftriaxone concentration ]
    Maximum measured plasma ceftriaxone concentration

  2. Tmax [ Time Frame: from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration ]
    Time to maximum measured plasma ceftriaxone concentration


Eligibility Criteria
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Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493220


Sponsors and Collaborators
Baxter Healthcare Corporation
Halozyme Therapeutics
Investigators
Layout table for investigator information
Study Director: George E Harb, MD Baxter Healthcare Corporation
More Information
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Publications of Results:

Layout table for additonal information
Responsible Party: Geroge E. Harb, MD, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00493220    
Other Study ID Numbers: 1838-004
First Posted: June 28, 2007    Key Record Dates
Results First Posted: December 2, 2011
Last Update Posted: December 2, 2011
Last Verified: October 2011
Keywords provided by Baxter Healthcare Corporation:
ceftriaxone
cephalosporins
pharmacokinetics
subcutaneous
 hyaluronoglucosaminidase
hyaluronidase
hyaluronan
rHuPH20
Additional relevant MeSH terms:
Layout table for MeSH terms
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents