HealthyPhase 1NCT01577589
A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects
A Phase 1 study testing 600 mg ceftaroline fosamil in 50 ml infusion volume, 600 ceftaroline fosamil in 250 ml infusion volume and 600 mg ceftaroline in 100 ml infusion volume in people with Healthy, run by Pfizer at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of Ceftaroline 600 mg when administered by varying infusion volumes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 600 mg ceftaroline fosamil in 50 ml infusion volume, 600 ceftaroline fosamil in 250 ml infusion volume and 600 mg ceftaroline in 100 ml infusion volume
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Sep 2012
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific requirements
- Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 3 months prior to enrollment, during the study, and for 3 months after completion of all study-related proceed
- Male volunteers must be willing to use barrier contraception from the first day of dosing until 3 months after the last dose of IP.
- Have a body mass index (BMI) between 18 and 30 kg/m2, and weigh at least 50 kg
- Healthy male and/or female volunteers between the ages of 18 to 75 years inclusive, with veins on the back of both hands and both forearms suitable for cannulation or repeated venipuncture.
Who cannot join
- Use of any other investigational compound or participation in another clinical trial within 1 month prior to first administration of IP in this study
- History of any clinically significant disease or disorder (e.g., neurological, haematological, psychiatric, gastrointestinal, hepatic, renal disease)
- Positive serology result on screening for serum hepatitis B surface antigen, hepatitis C antibody (HCV), or human immunodeficiency virus (HIV)
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Any clinically significant abnormalities in the physical examination, lab, 12-lead ECG or vital signs as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (Single-dose) of Ceftaroline in Healthy Subjects When Ceftaroline Fosamil is Diluted in Various Infusion Volume
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of Ceftaroline 600 mg when administered by varying infusion volumes.
Read the detailed description
A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (Single-dose) of Ceftaroline in Healthy Subjects when Ceftaroline Fosamil is Diluted in Various Infusion Volume
- Conditions
- Healthy
- Being tested
- 600 mg ceftaroline fosamil in 50 ml infusion volume, Placebo in 50 ml infusion volume, 600 ceftaroline fosamil in 250 ml infusion volume, Placebo in 250 ml infusion volume, 600 mg ceftaroline in 100 ml infusion volume
- Keywords
- Phase 1, healthy volunteers, cross-over study, ceftaroline fosamil, various infusion volumes, local tolerability, Cmax, tmax, AUC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
600 mg ceftaroline fosamil in 50 ml infusion volumeDrug
IV infusion
Placebo in 50 ml infusion volumeDrug
IV infusion
600 ceftaroline fosamil in 250 ml infusion volumeDrug
IV infusion
Placebo in 250 ml infusion volumeDrug
IV infusion
600 mg ceftaroline in 100 ml infusion volumeDrug
IV infusion
Placebo in 100 ml infusion volumeDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 600 mg ceftaroline fosamil in 50 ml infusion volume Receives: Drug: 600 mg ceftaroline fosamil in 50 ml infusion volume |
| B | Placebo comparator | Placebo in 50 ml infusion volume Receives: Drug: Placebo in 50 ml infusion volume |
| C | Experimental | 600 ceftaroline fosamil in 250 ml infusion volume Receives: Drug: 600 ceftaroline fosamil in 250 ml infusion volume |
| D | Placebo comparator | Placebo in 250 ml infusion volume Receives: Drug: Placebo in 250 ml infusion volume |
| E | Experimental | 600 mg ceftaroline in 100 ml infusion volume Receives: Drug: 600 mg ceftaroline in 100 ml infusion volume |
| F | Placebo comparator | Placebo in 100 ml infusion volume Receives: Drug: Placebo in 100 ml infusion volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour pharmacokinetic profile in terms of (see description) for ceftaroline following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Maximum plasma concentration (Cmax) Time to maximum concentration (tmax) Area under the concentration-time curve from zero to infinity (AUC) Area under the plasma concentration-time curve from zero to time of the last quantifiable concentrations [AUC(0-t)] Area under the plasma concentration-time curve from zero to 12 hours after the start of the infusion [AUC(0-12)]
Measured: Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose
24-hour pharmacokinetic profile in terms of (see description)for ceftaroline following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Apparent terminal elimination rate constant (Lz) Half-life associated with the terminal slope (t½Lz),mean residence time (MRT) Total body clearance of drug from plasma (CL) Volume of distribution based on the terminal phase(Vz) Volume of distribution at steady state (Vss) Cmax ratios of ceftaroline/ceftaroline fosamil and ceftaroline M-1/ceftaroline (RM/D,Cmax) AUC ratios of ceftaroline/ceftaroline fosamil and ceftaroline M-1/ceftaroline (RM/D,AUC)
Measured: Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose
Local tolerability in terms of adverse events including local infusion site tolerability for ceftaroline following ceftaroline 600 mg diluted in various infusion volumes every 12 hours for 72 hours
Baseline is defined as - Screening up.
Measured: From baseline to 14 days after first dose
Secondary outcomes (4)
Safety profile in terms of vital signs, ECG, laboratory variables, physical examination for ceftaroline following ceftaroline 600 mg diluted in various infusion volumes every 12 hours for 72 hours
Baseline is defnied as - Screening up
Measured: From baseline to 14 days after first dose
24-hour pharmacokinetic profile in terms of ( see description) for ceftaroline fosamil and ceftaroline M-1following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Maximum plasma concentration (Cmax) Time to maximum concentration (tmax) Area under the concentration-time curve from zero to infinity (AUC) Area under the plasma concentration-time curve from zero to time of the last quantifiable concentrations [AUC(0-t)] Area under the plasma concentration-time curve from zero to 12 hours after the start of the infusion [AUC(0-12)]
Measured: Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose
24-hour pharmacokinetic profile in terms of ( see description) for ceftaroline fosamil and ceftaroline M-1following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Apparent terminal elimination rate constant (Lz) Half-life associated with the terminal slope (t½Lz),mean residence time (MRT) Total body clearance of drug from plasma (CL) Volume of distribution based on the terminal phase(Vz) Volume of distribution at steady state (Vss) Cmax ratios of ceftaroline/ceftaroline fosamil and ceftaroline M-1/ceftaroline (RM/D,Cmax) AUC ratios of ceftaroline/ceftaroline fosamil and ceftaroline M-1/ceftaroline (RM/D,AUC)
Measured: Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose
Safety and tolerability profile in terms of adverse events, vital signs, ECG, laboratory variables, physical exam of ceftaroline following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Baseline is defined as- Screening up.
Measured: From baseline to 14 days after first dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Melnick, MD, Study director, AstraZeneca PharmaceuticalsC2C-7161800 Concord PikePO. Box 15437Wilmington De 19850-5437Elizabeth Tranter, MBCHB MRCP, Principal investigator, Hammersmith Medicines Research Cumberland Avenue London NW10 EW UKMirjana Kujacic, MD, Study chair, AstraZeneca Research and DevelopmentSE-431 83 MölndalSweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577589
- Sponsor's protocol ID
- D3720C00015
- Status last verified
- Sep 2017
- First submitted
- 5 Apr 2012
- Last updated
- 5 Sep 2017
- Results posted
- No
Publications
Edeki T, Kujacic M, Broadhurst H, Li J, Sunzel M. Safety, local tolerability and pharmacokinetics of ceftaroline fosamil administered in a reduced infusion volume. Br J Clin Pharmacol. 2014 Dec;78(6):1291-7. doi: 10.1111/bcp.12465.
PubMed 25041494
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (Single-dose) of Ceftaroline in Healthy Subjects When Ceftaroline Fosamil is Diluted in Various Infusion Volume
- ClinicalTrials.gov ID
- NCT01577589
- Acronym / sponsor ID
- D3720C00015
- Conditions
- Healthy
- Keywords
- Phase 1, healthy volunteers, cross-over study, ceftaroline fosamil, various infusion volumes, local tolerability, Cmax, tmax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Apr 2012 (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 purpose of this study is to assess the safety, tolerability, and pharmacokinetics of Ceftaroline 600 mg when administered by varying infusion volumes.
Detailed description
A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (Single-dose) of Ceftaroline in Healthy Subjects when Ceftaroline Fosamil is Diluted in Various Infusion Volume
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 600 mg ceftaroline fosamil in 50 ml infusion volume600 mg ceftaroline fosamil in 50 ml infusion volume |
| B | Placebo comparator | Drug: Placebo in 50 ml infusion volumePlacebo in 50 ml infusion volume |
| C | Experimental | Drug: 600 ceftaroline fosamil in 250 ml infusion volume600 ceftaroline fosamil in 250 ml infusion volume |
| D | Placebo comparator | Drug: Placebo in 250 ml infusion volumePlacebo in 250 ml infusion volume |
| E | Experimental | Drug: 600 mg ceftaroline in 100 ml infusion volume600 mg ceftaroline in 100 ml infusion volume |
| F | Placebo comparator | Drug: Placebo in 100 ml infusion volumePlacebo in 100 ml infusion volume |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study specific requirements
- Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 3 months prior to enrollment, during the study, and for 3 months after completion of all study-related proceed
- Male volunteers must be willing to use barrier contraception from the first day of dosing until 3 months after the last dose of IP.
- Have a body mass index (BMI) between 18 and 30 kg/m2, and weigh at least 50 kg
- Healthy male and/or female volunteers between the ages of 18 to 75 years inclusive, with veins on the back of both hands and both forearms suitable for cannulation or repeated venipuncture.
Key exclusion criteria (5 listed)
- Use of any other investigational compound or participation in another clinical trial within 1 month prior to first administration of IP in this study
- History of any clinically significant disease or disorder (e.g., neurological, haematological, psychiatric, gastrointestinal, hepatic, renal disease)
- Positive serology result on screening for serum hepatitis B surface antigen, hepatitis C antibody (HCV), or human immunodeficiency virus (HIV)
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Any clinically significant abnormalities in the physical examination, lab, 12-lead ECG or vital signs as judged by the investigator
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 |
|---|---|---|
| 600 mg ceftaroline fosamil in 50 ml infusion volumeIV infusion | Drug | A |
| Placebo in 50 ml infusion volumeIV infusion | Drug | B |
| 600 ceftaroline fosamil in 250 ml infusion volumeIV infusion | Drug | C |
| Placebo in 250 ml infusion volumeIV infusion | Drug | D |
| 600 mg ceftaroline in 100 ml infusion volumeIV infusion | Drug | E |
| Placebo in 100 ml infusion volumeIV infusion | Drug | F |
Primary outcome
24-hour pharmacokinetic profile in terms of (see description) for ceftaroline following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Time frame: Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose
Maximum plasma concentration (Cmax) Time to maximum concentration (tmax) Area under the concentration-time curve from zero to infinity (AUC) Area under the plasma concentration-time curve from zero to time of the last quantifiable concentrations [AUC(0-t)] Area under the plasma concentration-time curve from zero to 12 hours after the start of the infusion [AUC(0-12)]
24-hour pharmacokinetic profile in terms of (see description)for ceftaroline following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Time frame: Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose
Apparent terminal elimination rate constant (Lz) Half-life associated with the terminal slope (t½Lz),mean residence time (MRT) Total body clearance of drug from plasma (CL) Volume of distribution based on the terminal phase(Vz) Volume of distribution at steady state (Vss) Cmax ratios of ceftaroline/ceftaroline fosamil and ceftaroline M-1/ceftaroline (RM/D,Cmax) AUC ratios of ceftaroline/ceftaroline fosamil and ceftaroline M-1/ceftaroline (RM/D,AUC)
Local tolerability in terms of adverse events including local infusion site tolerability for ceftaroline following ceftaroline 600 mg diluted in various infusion volumes every 12 hours for 72 hours
Time frame: From baseline to 14 days after first dose
Baseline is defined as - Screening up.
4 secondary outcomes
Safety profile in terms of vital signs, ECG, laboratory variables, physical examination for ceftaroline following ceftaroline 600 mg diluted in various infusion volumes every 12 hours for 72 hours
Time frame: From baseline to 14 days after first dose
24-hour pharmacokinetic profile in terms of ( see description) for ceftaroline fosamil and ceftaroline M-1following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Time frame: Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose
24-hour pharmacokinetic profile in terms of ( see description) for ceftaroline fosamil and ceftaroline M-1following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Time frame: Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose
Safety and tolerability profile in terms of adverse events, vital signs, ECG, laboratory variables, physical exam of ceftaroline following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes
Time frame: From baseline to 14 days after first dose)
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 5 Sep 2017.
- Derived from this study: PubMed 25041494Edeki T, Kujacic M, Broadhurst H, Li J, Sunzel M. Safety, local tolerability and pharmacokinetics of ceftaroline fosamil administered in a reduced infusion volume. Br J Clin Pharmacol. 2014 Dec;78(6):1291-7. doi: 10.1111/bcp.12465.
- Related InfoLink provided by the sponsor.
- CSR-D3720C00015.pdfLink provided by the sponsor.
- Clinical Study Protocol RedactedLink 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.
David Melnick, MD study director
AstraZeneca PharmaceuticalsC2C-7161800 Concord PikePO. Box 15437Wilmington De 19850-5437
Elizabeth Tranter, MBCHB MRCP principal investigator
Hammersmith Medicines Research Cumberland Avenue London NW10 EW UK
Mirjana Kujacic, MD study chair
AstraZeneca Research and DevelopmentSE-431 83 MölndalSweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 600 mg ceftaroline fosamil in 50 ml infusion volume, 600 ceftaroline fosamil in 250 ml infusion volume and 600 mg ceftaroline in 100 ml infusion volume in people with Healthy, run by Pfizer at 1 site in United Kingdom.
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 5 inclusion and 5 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 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
24-hour pharmacokinetic profile in terms of (see description) for ceftaroline following single-dose administration of ceftaroline fosamil 600 mg diluted in various infusion volumes (time frame: Pre-dose, 20 min, 40 min, 60 min, 65 min, 75 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 18 h, 24 h post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01577589, which also lists 1 linked publication.
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 5 Sep 2017.