Staphylococcal Skin Infections Clinical Trial
Official title:
An Exploratory Study to Evaluate the Penetration of Ceftobiprole Into Soft Tissue Determined by In Vivo Microdialysis in Healthy Volunteers
Verified date | July 2012 |
Source | Basilea Pharmaceutica |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Basilea Pharmaceutica |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 1 pre- and post-dose during the pilot study and on Days 1 and 2 during the main study | No | |
Secondary | To assess the safety and tolerability of ceftobiprole after a single intravenous (iv) infusion. | 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 | No |
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