Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers
Primary Purpose
Staphylococcal Skin Infections, Streptococcal Infections
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ceftobiprole
Sponsored by
About this trial
This is an interventional basic science trial for Staphylococcal Skin Infections focused on measuring Staphylococcal Skin Infections, Streptococcal Infections
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI between 18 to 29 kg/m2
- Nonsmoker
- Normal renal function
Exclusion Criteria:
- History of gastric or duodenal ulcer
- History of allergies or hypersensitivity (including penicillin, cephalosporins, or other ß-lactams or quinolones)
- Hypersensitivity or intolerance to heparin
- History of drug or alcohol abuse
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
001
Arm Description
Ceftobiprole 500 mg, single infusion over 2 hours
Outcomes
Primary Outcome Measures
To measure the penetration of ceftobiprole into subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration-versus-time profiles of ceftobiprole in these tissues and in plasma.
Secondary Outcome Measures
To assess the safety and tolerability of ceftobiprole after a single intravenous (iv) infusion.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01026740
Brief Title
Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers
Official Title
An Exploratory Study to Evaluate the Penetration of Ceftobiprole Into Soft Tissue Determined by In Vivo Microdialysis in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Basilea Pharmaceutica
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to measure the penetration of ceftobiprole into subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration over time of ceftobiprole in these tissues and in plasma after administration of a single intravenous (i.v.) infusion (directly into the vein) of ceftobiprole 500 mg administered over 2 hours. The secondary objective was to further assess the safety and tolerability of ceftobiprole after a single i.v. infusion.
Detailed Description
This is a single-center, open-label (all patients involved know the identity of the drug), single-arm, nonrandomized study of ceftobiprole in healthy men and women. The study is conducted in 2 parts: a pilot study and a main study. Each study (i.e. the pilot study and the main study) consists of 3 phases: a pretreatment phase that includes up to a 21-day screening period, an open-label treatment phase (1 day in the pilot study and 2 days in the main study), and a posttreatment phase that included the end of study evaluations and follow-up study visit or telephone contact planned for 1 to 2 weeks after discharge from the study unit. Serial blood and dialysis samples will be collected at specified time points from predose through 24 hours after the start of the infusion for estimation of ceftobiprole and ceftobiprole medocaril concentrations. Additional samples will be collected for measurement of protein binding. The study will include the following evaluations of safety and tolerability: adverse events, clinical laboratory tests (including hematology, serum chemistry, and urinalysis), electrocardiogram (ECG), vital signs, physical examination, serology, pregnancy tests, urine drug screen, and alcohol breath test. In the pilot study, Ceftobiprole will be locally administered via a microdialysis probe at a concentration of approximately 30 µg/mL for 60 minutes. In the main Study, each volunteer will receive ceftobiprole locally via the microdialysis probe. After the washout period determined by the pilot study, each volunteer will receive a single 2-hour i.v. infusion of ceftobiprole.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Skin Infections, Streptococcal Infections
Keywords
Staphylococcal Skin Infections, Streptococcal Infections
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
Ceftobiprole 500 mg, single infusion over 2 hours
Intervention Type
Drug
Intervention Name(s)
Ceftobiprole
Intervention Description
single intravenous (i.v.) infusion, 500 mg ceftobiprole administered over 2 hours.
Primary Outcome Measure Information:
Title
To measure the penetration of ceftobiprole into subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration-versus-time profiles of ceftobiprole in these tissues and in plasma.
Time Frame
Day 1 pre- and post-dose during the pilot study and on Days 1 and 2 during the main study
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of ceftobiprole after a single intravenous (iv) infusion.
Time Frame
Approximately 5 weeks during the pilot study including screening, treatment, and posttreatment follow up and for approximately 5 weeks during the main study including screening, treatment, and posttreatment follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI between 18 to 29 kg/m2
Nonsmoker
Normal renal function
Exclusion Criteria:
History of gastric or duodenal ulcer
History of allergies or hypersensitivity (including penicillin, cephalosporins, or other ß-lactams or quinolones)
Hypersensitivity or intolerance to heparin
History of drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=732&filename=CR011416_REF1.pdf
Description
An Exploratory Study to Evaluate the Penetration of Ceftobiprole Into Soft Tissue Determined by In Vivo Microdialysis in Healthy Volunteers
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=732&filename=CR011416_CSR.pdf
Description
An Exploratory Study to Evaluate the Penetration of Ceftobiprole Into Soft Tissue Determined by In Vivo Microdialysis in Healthy Volunteers
Learn more about this trial
Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers
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