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

NCT ID: NCT01030731

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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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. This is a Phase 1, open label study (all patients involved know the identity of the drug). Healthy volunteers will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with ESRD on hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately after dialysis. Plasma and urine samples will be assayed for ceftobiprole. Samples will be collected over a 48 hour period of time. Safety evaluations will include monitoring of adverse events, clinical laboratory tests (hematology and serum chemistry in all patients/volunteers, and urinalysis in healthy volunteers subjects), pregnancy testing, vital signs, physical examination, and recording of concomitant medications. Healthy volunteers will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with ESRD on hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately after dialysis.

Conditions

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Staphylococcal Skin Infections Streptococcal Infections

Keywords

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

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ceftobiprole (end-stage renal disease subjects).

Ceftobiprole 250mg single dose over 2 hours.

Group Type EXPERIMENTAL

Ceftobiprole

Intervention Type DRUG

Ceftobiprole 250mg single dose over 2 hours.

Ceftobiprole (healthy subjects)

Ceftobiprole 250 mg single dose over 2 hours.

Group Type ACTIVE_COMPARATOR

Ceftobiprole

Intervention Type DRUG

Ceftobiprole 250mg single dose over 2 hours.

Interventions

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Ceftobiprole

Ceftobiprole 250mg single dose over 2 hours.

Intervention Type DRUG

Eligibility Criteria

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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 immunodeficiency virus (HIV)
* Recent febrile illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role collaborator

Basilea Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=746&filename=CR012448_CSR.pdf

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

Other Identifiers

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CR012448

Identifier Type: -

Identifier Source: org_study_id