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

NCT01026558 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-08-28

No results posted yet for this study

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

Interventions

DRUG

Ceftobiprole

Ceftobiprole, 500 mg as single iv infusion over 2 hours

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2007-11-30
Completion
2007-11-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01026558 on ClinicalTrials.gov