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

Obesity Clinical Trial

Official title:

Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026558
• Other study ID #: CR014185
• Secondary ID: CSI-1008
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2009
• Last updated: August 27, 2012
• Start date: August 2007
• Est. completion date: November 2007

Study information

• Verified date: August 2012
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Obesity
• Skin Diseases, Infectious
• Staphylococcal Skin Infections
• Streptococcal Infections

Intervention

Drug:
• Ceftobiprole
Ceftobiprole, 500 mg as single iv infusion over 2 hours

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Basilea Pharmaceutica	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients		up to 30 days (up to 21 days screening plus 2 days open-label treatment phase plus 1-week follow-up).	No
Secondary	To assess the pharmacodynamics of ceftobiprole in morbidly obese patients and non-obese patients.		Up to 30 days (up to 21 days screening plus 2 days open label treatment phase plus 1-week follow-up)	No
Secondary	To assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.		Throughout the study from Day -1 through the post-study follow up	No

External Links

•   Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Subjects