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Ceftobiprole

Phase 1

Staphylococcal Skin Infections | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Aug 28, 2012

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Ceftobiprole · 1 trial · 2 indications

Phase 1 1
NCT01030731Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal DiseaseStaphylococcal Skin Infections
COMPLETED12 Analytics
PHASE1COMPLETED
Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease
Staphylococcal Skin Infections
NCT0103073112
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Ceftobiprole (end-stage renal disease subjects).EXPERIMENTALCeftobiprole 250mg single dose over 2 hours.
Ceftobiprole (healthy subjects)ACTIVE_COMPARATORCeftobiprole 250 mg single dose over 2 hours.

Interventions

NameTypeDescription
CeftobiproleDRUGCeftobiprole 250mg single dose over 2 hours.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy volunteer or be a hemodialysis patient in stable physical condition with a diagnosis of ESRD and requiring hemodialysis treatment 3 times per week Exclusion Criteria: * History of repeated severe nausea * History of infection with hepatitis B, hepatitis C, or human i...

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Frequently asked questions about Ceftobiprole

What is Ceftobiprole used for?

Ceftobiprole is a small molecule being developed for the treatment of staphylococcal skin infections and streptococcal infections. It is currently in Phase 1 clinical development as an investigational drug for these infectious disease indications.

Who makes Ceftobiprole?

Ceftobiprole is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 1 clinical development for staphylococcal skin infections.

What phase is Ceftobiprole in?

Ceftobiprole is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 study has been completed, involving 12 participants.

What clinical trials is Ceftobiprole in?

Ceftobiprole has one completed clinical trial, registered as NCT01030731. This Phase 1 study was a pharmacokinetic investigation in healthy volunteers and healthy patients with end stage renal disease, with 12 male participants aged 18 years and older.

Is Ceftobiprole the same as any other drug?

Ceftobiprole is the drug name used in clinical development. No alternative names have been associated with this asset in the available trial information.