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

Baxter

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SC HYLENEX and Ceftriaxone; Drug: IV Ceftriaxone; Drug: SC Placebo and Ceftriaxone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00493220

1838-004

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 6 patient groups

HYLENEX SC, Placebo SC, IV

Experimental group

Description:

subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention

Treatment:

Drug: SC Placebo and Ceftriaxone

Drug: IV Ceftriaxone

Drug: SC HYLENEX and Ceftriaxone

HYLENEX SC, IV, Placebo SC

Experimental group

Description:

subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention

Treatment:

Drug: SC Placebo and Ceftriaxone

Drug: IV Ceftriaxone

Drug: SC HYLENEX and Ceftriaxone

Placebo SC, HYLENEX SC, IV

Experimental group

Description:

subcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention

Treatment:

Drug: SC Placebo and Ceftriaxone

Drug: IV Ceftriaxone

Drug: SC HYLENEX and Ceftriaxone

Placebo SC, IV, HYLENEX SC

Experimental group

Description:

subcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention

Treatment:

Drug: SC Placebo and Ceftriaxone

Drug: IV Ceftriaxone

Drug: SC HYLENEX and Ceftriaxone

IV, HYLENEX SC, Placebo SC

Experimental group

Description:

IV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention

Treatment:

Drug: SC Placebo and Ceftriaxone

Drug: IV Ceftriaxone

Drug: SC HYLENEX and Ceftriaxone

IV, Placebo SC, HYLENEX SC

Experimental group

Description:

IV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention

Treatment:

Drug: SC Placebo and Ceftriaxone

Drug: IV Ceftriaxone

Drug: SC HYLENEX and Ceftriaxone