Phase 1
Completed N=30
Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration
Healthy
Source: ClinicalTrials.gov NCT00493220 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: AUC0-t — 1139.3; 1115.6; 1065.3 μg*hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-t |
1139.3; 1115.6; 1065.3 | — |
| PRIMARY AUC0-inf |
1162.6; 1141.3; 1085.8 | — |
| SECONDARY Cmax |
92.0; 82.2; 150 | — |
| SECONDARY Tmax |
2.02; 3.02; 0.502 | <0.01 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00493220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.