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

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Basilea Pharmaceutica

Status and phase

Completed
Phase 1

Conditions

Streptococcal Infections
Staphylococcal Skin Infections

Treatments

Drug: Ceftobiprole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01030731
CR012448

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

12 participants in 2 patient groups

Ceftobiprole (end-stage renal disease subjects).
Experimental group
Description:
Ceftobiprole 250mg single dose over 2 hours.
Treatment:
Drug: Ceftobiprole
Ceftobiprole (healthy subjects)
Active Comparator group
Description:
Ceftobiprole 250 mg single dose over 2 hours.
Treatment:
Drug: Ceftobiprole

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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