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

August 27, 2012 updated by: Basilea Pharmaceutica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ceftobiprole (not morbidly obese subjects)
Ceftobiprole 500 mg single-dose over 2 hours.
Drug: Ceftobiprole
Ceftobiprole, 500 mg as single iv infusion over 2 hours
Experimental: Ceftobiprole (morbidly obese subjects)
Ceftobiprole 500 mg single-dose over 2 hours.
Drug: Ceftobiprole
Ceftobiprole, 500 mg as single iv infusion over 2 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients
Time Frame: up to 30 days (up to 21 days screening plus 2 days open-label treatment phase plus 1-week follow-up).
up to 30 days (up to 21 days screening plus 2 days open-label treatment phase plus 1-week follow-up).

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the pharmacodynamics of ceftobiprole in morbidly obese patients and non-obese patients.
Time Frame: Up to 30 days (up to 21 days screening plus 2 days open label treatment phase plus 1-week follow-up)
Up to 30 days (up to 21 days screening plus 2 days open label treatment phase plus 1-week follow-up)
To assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.
Time Frame: Throughout the study from Day -1 through the post-study follow up
Throughout the study from Day -1 through the post-study follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basilea Pharmaceutica

Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 3, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

August 28, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR014185
  • CSI-1008 (Other Identifier: Basilea (Internal Reference))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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