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

Basilea Pharmaceutica

Status and phase: Completed; Phase 1

Conditions: Streptococcal Infections; Obesity; Staphylococcal Skin Infections

Treatments: Drug: Ceftobiprole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01026558

CR014185

CSI-1008 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is an open-label (all people involved know the identity of the intervention), parallel-group, Phase 1 study in morbidly obese and non-obese men and women. A total of 25 patients (12 morbidly obese and 13 non-obese) patients will be enrolled in the study. Morbidly obese and nonobese patients are matched individually 1:1 by age (±10 years), sex, and renal function (as defined by creatinine levels in the urine). There are 4 phases in the clinical study: the pretreatment (screening/baseline) phase of up to 21 days; the 2-day open-label treatment phase when each patients receives a single 2-hour intravenous (directly into the vein) infusion of ceftobiprole 500 mg followed by multiple (up to 15) blood and urine samples drawn over the 24 hours following study drug administration; and the follow-up phase of approximately 1 week after the last blood sample when each patient will be monitored by telephone for development of new adverse events and assessment of ongoing adverse events. Each patient receives a single 2-hour infusion (directly into the vein) of ceftobiprole 500 mg

Enrollment: 25 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Ceftobiprole (not morbidly obese subjects)

Active Comparator group

Description:

Ceftobiprole 500 mg single-dose over 2 hours.

Treatment:

Drug: Ceftobiprole

Ceftobiprole (morbidly obese subjects)

Experimental group

Description:

Ceftobiprole 500 mg single-dose over 2 hours.

Treatment:

Drug: Ceftobiprole