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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Basilea Pharmaceutica
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Ceftobiprole; Ceftobiprole medocaril; Cephalosporins

Criteria

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