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Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration

Information source: Baxter Healthcare Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: SC HYLENEX and Ceftriaxone (Drug); SC Placebo and Ceftriaxone (Drug); IV Ceftriaxone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Baxter Healthcare Corporation

Official(s) and/or principal investigator(s):
George E Harb, MD, Study Director, Affiliation: Baxter Healthcare Corporation

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

AUC0-t

AUC0-inf

Secondary outcome:

Cmax

Tmax

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: June 2007
Last updated: October 24, 2011

Page last updated: August 23, 2015

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