Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease

NCT01030731 | Completed Phase 1

• 1 other identifier: CR012448
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single 250-mg intravenous (IV) infusion (given directly into the vein) for 2 hours, before and after dialysis to patients with end-stage renal disease (ESRD) requiring hemodialysis or healthy volunteers.

Conditions

Staphylococcal Skin Infections; Streptococcal Infections

Keywords

Renal Dialysis, Ceftobiprole; Skin and soft tissue Infections; Staphylococcal Skin Infections; Streptococcal Infection

Outcome Measures

Primary Outcomes (1)

• To characterize the pharmacokinetics of ceftobiprole and its open-ring metabolite in patients undergoing dialysis.

  Days 1 through 3 of study period 1 for healthy volunteers with normal renal function and Days 1 through 5 of study period 1 (predialysis) and study period 2 (postdialysis) for patients with ESRD

Secondary Outcomes (3)

• To assess the safety and tolerability of ceftobiprole in patients with ESRD undergoing dialysis and in a control group of healthy volunteers with normal renal function

  31 days for healthy volunteers and 52 days for patients with ESRD, including the screening, treatment, end-of-study, and follow-up phase

• To compare the pharmacokinetics of ceftobiprole and its open-ring metabolite in patients with ESRD undergoing hemodialysis with a control group of healthy volunteers with normal renal function

  Days 1 through 3 of study period 1 for healthy volunteers with normal renal function and Days 1 through 5 of study period 1 (predialysis) and study period 2 (postdialysis) for patients with ESRD

• To determine the extent of the ceftobiprole dose removed by hemodialysis

  Days 1 through 3 of study period 1 for healthy volunteers with normal renal function and Days 1 through 5 of study period 1 (predialysis) and study period 2 (postdialysis) for patients with ESRD

Study Arms (2)

Ceftobiprole (end-stage renal disease subjects).

EXPERIMENTAL

Ceftobiprole 250mg single dose over 2 hours.

Drug: Ceftobiprole

Ceftobiprole (healthy subjects)

ACTIVE COMPARATOR

Ceftobiprole 250 mg single dose over 2 hours.

Drug: Ceftobiprole

Interventions

Ceftobiprole DRUG

Ceftobiprole 250mg single dose over 2 hours.

Ceftobiprole (end-stage renal disease subjects).; Ceftobiprole (healthy subjects)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteer or be a hemodialysis patient in stable physical condition with a diagnosis of ESRD and requiring hemodialysis treatment 3 times per week

You may not qualify if:

• History of repeated severe nausea
• History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
• Recent febrile illness

Sponsors & Collaborators

• Basilea Pharmaceutica: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Related Links

• Pharmacokinetic Study of Ceftobiprole in Healthy Volunteers and Patients With End Stage Renal Disease Receiving Hemodialysis

MeSH Terms

Conditions

Staphylococcal Skin Infections; Streptococcal Infections; Soft Tissue 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
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: May 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: August 28, 2012

Record last verified: 2012-08