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

NCT01026558 | Completed Phase 1

• 2 other identifiers: CR014185CSI-1008
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity; Staphylococcal Skin Infections; Streptococcal Infections

Keywords

Obesity, Ceftobiprole; Skin Infections; Staphylococcal Skin Infections; Bacterial Skin Infections; Streptococcal Infection

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (2)

• 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)

• 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

Study Arms (2)

Ceftobiprole (not morbidly obese subjects)

ACTIVE COMPARATOR

Ceftobiprole 500 mg single-dose over 2 hours.

Drug: Ceftobiprole

Ceftobiprole (morbidly obese subjects)

EXPERIMENTAL

Ceftobiprole 500 mg single-dose over 2 hours.

Drug: Ceftobiprole

Interventions

Ceftobiprole DRUG

Ceftobiprole, 500 mg as single iv infusion over 2 hours

Ceftobiprole (morbidly obese subjects); Ceftobiprole (not morbidly obese subjects)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) =or \> 40 kg/m2 or normal BMI between 18-30
• Blood pressure 90-140 mm
• Non-smoker

You may not qualify if:

• History of medically significant illness
• Uncontrolled hypertension
• Uncontrolled high blood cholesterol and triglycerides

Sponsors & Collaborators

• Basilea Pharmaceutica: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Related Links

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

MeSH Terms

Conditions

Obesity; Staphylococcal Skin Infections; Streptococcal Infections; Cellulitis

Interventions

ceftobiprole

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: August 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: August 28, 2012

Record last verified: 2012-08