ObesityPhase 1NCT01026558
A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients
A Phase 1 study testing Ceftobiprole in people with Obesity and Staphylococcal Skin Infections, run by Basilea Pharmaceutica.
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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Staphylococcal Skin Infections, Streptococcal Infections
- What is being tested?
- Ceftobiprole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Nov 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) =or > 40 kg/m2 or normal BMI between 18-30
- Blood pressure 90-140 mm
- Non-smoker
Who cannot join
- History of medically significant illness
- Uncontrolled hypertension
- Uncontrolled high blood cholesterol and triglycerides
About this study
Official title: 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.
Read the 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
- Being tested
- Ceftobiprole
- Keywords
- Obesity, Ceftobiprole, Skin Infections, Staphylococcal Skin Infections, Bacterial Skin Infections, Streptococcal Infection
- Medical subject headings
- Obesity, Staphylococcal Skin Infections, Streptococcal Infections, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftobiproleDrug
Ceftobiprole, 500 mg as single iv infusion over 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Ceftobiprole (not morbidly obese subjects) | Active comparator | Ceftobiprole 500 mg single-dose over 2 hours. Receives: Drug: Ceftobiprole |
| Ceftobiprole (morbidly obese subjects) | Experimental | Ceftobiprole 500 mg single-dose over 2 hours. Receives: Drug: Ceftobiprole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients
Measured: 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.
Measured: 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.
Measured: Throughout the study from Day -1 through the post-study follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startAug 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026558
- Sponsor's protocol ID
- CR014185
- Other IDs
- CSI-1008
- Status last verified
- Aug 2012
- First submitted
- 3 Dec 2009
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Patients
- ClinicalTrials.gov ID
- NCT01026558
- Acronym / sponsor ID
- CR014185
- Keywords
- Obesity, Ceftobiprole, Skin Infections, Staphylococcal Skin Infections, Bacterial Skin Infections, Streptococcal Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- Aug 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 4 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftobiprole (not morbidly obese subjects) | Active comparator | Drug: CeftobiproleCeftobiprole 500 mg single-dose over 2 hours. |
| Ceftobiprole (morbidly obese subjects) | Experimental | Drug: CeftobiproleCeftobiprole 500 mg single-dose over 2 hours. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) =or > 40 kg/m2 or normal BMI between 18-30
- Blood pressure 90-140 mm
- Non-smoker
Key exclusion criteria (3 listed)
- History of medically significant illness
- Uncontrolled hypertension
- Uncontrolled high blood cholesterol and triglycerides
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeftobiproleCeftobiprole, 500 mg as single iv infusion over 2 hours | Drug | Ceftobiprole (morbidly obese subjects), Ceftobiprole (not morbidly obese subjects) |
Primary outcome
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).
2 secondary outcomes
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
- Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese SubjectsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ceftobiprole in people with Obesity and Staphylococcal Skin Infections, run by Basilea Pharmaceutica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2012; AzTrials last refreshed its copy on 6 Nov 2026.