A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare 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 in morbidly obese patients and non-obese patients. The secondary objectives are to assess the pharmacodynamics (the study of the action or effects a drug has on the body) and to assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.

• 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:

• Body mass index (BMI) =or > 40 kg/m2 or normal BMI between 18-30

• Blood pressure 90-140 mm

• Non-smoker

Exclusion Criteria:

• History of medically significant illness

• Uncontrolled hypertension

• Uncontrolled high blood cholesterol and triglycerides