Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers

NCT01026740 | Completed Phase 1

• 2 other identifiers: CR011416CSI-1002
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Staphylococcal Skin Infections; Streptococcal Infections

Keywords

Staphylococcal Skin Infections; Streptococcal Infections

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

001

EXPERIMENTAL

Ceftobiprole 500 mg, single infusion over 2 hours

Drug: Ceftobiprole

Interventions

Ceftobiprole DRUG

single intravenous (i.v.) infusion, 500 mg ceftobiprole administered over 2 hours.

001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI between 18 to 29 kg/m2
• Nonsmoker
• Normal renal function

You may not qualify if:

• 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

Sponsors & Collaborators

• Basilea Pharmaceutica: lead

Related Links

• An Exploratory Study to Evaluate the Penetration of Ceftobiprole Into Soft Tissue Determined by In Vivo Microdialysis in Healthy Volunteers
• An Exploratory Study to Evaluate the Penetration of Ceftobiprole Into Soft Tissue Determined by In Vivo Microdialysis in Healthy Volunteers

MeSH Terms

Conditions

Staphylococcal Skin Infections; Streptococcal Infections

Interventions

ceftobiprole

Condition Hierarchy (Ancestors)

Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: June 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: July 30, 2012

Record last verified: 2012-07