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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


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
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