HealthyPhase 1INFUSE-CftrxNCT00493220
Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration
A Phase 1 study testing SC HYLENEX and Ceftriaxone and IV Ceftriaxone in people with Healthy, run by Baxter Healthcare Corporation.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SC HYLENEX and Ceftriaxone and IV Ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Sep 2007
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this 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
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.
- Conditions
- Healthy
- Being tested
- SC HYLENEX and Ceftriaxone, SC Placebo and Ceftriaxone, IV Ceftriaxone
- Keywords
- ceftriaxone, cephalosporins, pharmacokinetics, subcutaneous, hyaluronoglucosaminidase, hyaluronidase, hyaluronan, rHuPH20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC HYLENEX and CeftriaxoneDrug
Also called HYLENEX recombinant, hyaluronoglucosaminidase, hyaluronidase, rHuPH20
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)
SC Placebo and CeftriaxoneDrug
Also called saline, normal saline, 0.9% sodium chloride injection
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)
IV CeftriaxoneDrug
Also called ceftriaxone
single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)
| Study group | Role | What they receive |
|---|---|---|
| HYLENEX SC, Placebo SC, IV | Experimental | subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention Receives: Drug: SC HYLENEX and Ceftriaxone; Drug: SC Placebo and Ceftriaxone; Drug: IV Ceftriaxone |
| HYLENEX SC, IV, Placebo SC | Experimental | subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention Receives: Drug: SC HYLENEX and Ceftriaxone; Drug: SC Placebo and Ceftriaxone; Drug: IV Ceftriaxone |
| Placebo SC, HYLENEX SC, IV | Experimental | subcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention Receives: Drug: SC HYLENEX and Ceftriaxone; Drug: SC Placebo and Ceftriaxone; Drug: IV Ceftriaxone |
| Placebo SC, IV, HYLENEX SC | Experimental | subcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention Receives: Drug: SC HYLENEX and Ceftriaxone; Drug: SC Placebo and Ceftriaxone; Drug: IV Ceftriaxone |
| IV, HYLENEX SC, Placebo SC | Experimental | IV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention Receives: Drug: SC HYLENEX and Ceftriaxone; Drug: SC Placebo and Ceftriaxone; Drug: IV Ceftriaxone |
| IV, Placebo SC, HYLENEX SC | Experimental | IV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention Receives: Drug: SC HYLENEX and Ceftriaxone; Drug: SC Placebo and Ceftriaxone; Drug: IV Ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)
Measured: Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration
AUC0-inf
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)
Measured: from the start of ceftriaxone administration to infinity
Secondary outcomes (2)
Cmax
Maximum measured plasma ceftriaxone concentration
Measured: at the time of the highest measured plasma ceftriaxone concentration
Tmax
Time to maximum measured plasma ceftriaxone concentration
Measured: from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Halozyme Therapeutics
- Investigators
- George E Harb, MD, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493220
- Sponsor's protocol ID
- 1838-004
- Acronym
- INFUSE-Cftrx
- Status last verified
- Oct 2011
- First submitted
- 26 Jun 2007
- Last updated
- 2 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Harb G, Lebel F, Battikha J, Thackara JW. Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. Curr Med Res Opin. 2010 Feb;26(2):279-88. doi: 10.1185/03007990903432900.
PubMed 19947907
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00493220
- Acronym / sponsor ID
- INFUSE-Cftrx / 1838-004
- Conditions
- Healthy
- Keywords
- ceftriaxone, cephalosporins, pharmacokinetics, subcutaneous, hyaluronoglucosaminidase, hyaluronidase, hyaluronan, rHuPH20
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Halozyme Therapeutics
- Study start
- Jun 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Posted 2 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HYLENEX SC, Placebo SC, IV | Experimental | Drug: SC HYLENEX and Ceftriaxone, Drug: SC Placebo and Ceftriaxone, Drug: IV Ceftriaxonesubcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention |
| HYLENEX SC, IV, Placebo SC | Experimental | Drug: SC HYLENEX and Ceftriaxone, Drug: SC Placebo and Ceftriaxone, Drug: IV Ceftriaxonesubcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention |
| Placebo SC, HYLENEX SC, IV | Experimental | Drug: SC HYLENEX and Ceftriaxone, Drug: SC Placebo and Ceftriaxone, Drug: IV Ceftriaxonesubcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention |
| Placebo SC, IV, HYLENEX SC | Experimental | Drug: SC HYLENEX and Ceftriaxone, Drug: SC Placebo and Ceftriaxone, Drug: IV Ceftriaxonesubcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention |
| IV, HYLENEX SC, Placebo SC | Experimental | Drug: SC HYLENEX and Ceftriaxone, Drug: SC Placebo and Ceftriaxone, Drug: IV CeftriaxoneIV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention |
| IV, Placebo SC, HYLENEX SC | Experimental | Drug: SC HYLENEX and Ceftriaxone, Drug: SC Placebo and Ceftriaxone, Drug: IV CeftriaxoneIV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC HYLENEX and CeftriaxoneAlso: HYLENEX recombinant, hyaluronoglucosaminidase, hyaluronidase, rHuPH20single, 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) | Drug | HYLENEX SC, IV, Placebo SC, HYLENEX SC, Placebo SC, IV, IV, HYLENEX SC, Placebo SC, IV, Placebo SC, HYLENEX SC, Placebo SC, HYLENEX SC, IV, Placebo SC, IV, HYLENEX SC |
| SC Placebo and CeftriaxoneAlso: saline, normal saline, 0.9% sodium chloride injectionsingle, 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) | Drug | HYLENEX SC, IV, Placebo SC, HYLENEX SC, Placebo SC, IV, IV, HYLENEX SC, Placebo SC, IV, Placebo SC, HYLENEX SC, Placebo SC, HYLENEX SC, IV, Placebo SC, IV, HYLENEX SC |
| IV CeftriaxoneAlso: ceftriaxonesingle, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes) | Drug | HYLENEX SC, IV, Placebo SC, HYLENEX SC, Placebo SC, IV, IV, HYLENEX SC, Placebo SC, IV, Placebo SC, HYLENEX SC, Placebo SC, HYLENEX SC, IV, Placebo SC, IV, HYLENEX SC |
Primary outcome
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)
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)
2 secondary outcomes
Cmax
Time frame: at the time of the highest measured plasma ceftriaxone concentration
Tmax
Time frame: from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19947907Harb G, Lebel F, Battikha J, Thackara JW. Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. Curr Med Res Opin. 2010 Feb;26(2):279-88. doi: 10.1185/03007990903432900.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George E Harb, MD study director
Baxter Healthcare Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC HYLENEX and Ceftriaxone and IV Ceftriaxone in people with Healthy, run by Baxter Healthcare Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00493220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2011.