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Ceftobiprole

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
ACTIVE_CONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01030731Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal DiseasePHASE1 COMPLETED 12 — — May 1, 2007Aug 1, 2007Aug 28, 2012 - —
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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 — 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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