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

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