Healthy Male and Female Japanese VolunteersPhase 1NCT01291602
A Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects
A Phase 1 study testing NXL104 and CAZ104 in people with Healthy Male and Female Japanese Volunteers, run by Pfizer at 2 sites in United States.
Trial summary
This is a single and multiple dose study in healthy male and female (of non-childbearing potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Male and Female Japanese Volunteers
- What is being tested?
- NXL104 and CAZ104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Apr 2011
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be considered as 'Japanese', both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for more than 5 years
- Have a body mass index (BMI) between 17 and 27 kg/m2 inclusive and weigh at least 45 kg and no more than 100 kg.
- Females must not be lactating, and must be of non-childbearing potential (post-menopausal at least 12 months or documented irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
Who cannot join
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- Symptoms of a clinically significant illness in the 3 months before the study
- History of hypersensitivity (eg, anaphylaxis), serious allergy, or any serious reaction to carbapenem, cephalosporins, or other β-lactam antibiotics
- Use within 14 days prior to the first study dose of any over-the-counter (including St. John's Wort or any herbal products) or prescription medication
- Smoker of more than 5 cigarettes/day or equivalent use of nicotine products during the previous 3 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Baltimore, Maryland
Research Site
Glendale, California
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects
This is a single and multiple dose study in healthy male and female (of non-childbearing potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime.
- Being tested
- NXL104, CAZ104, Placebo
- Keywords
- NXL104, ceftazidime, CAZ104, Healthy Japanese volunteers, Phase 1, Single and Multiple Dose Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXL104Drug
IV Solution
CAZ104Drug
IV Solution
PlaceboDrug
IV saline
| Study group | Role | What they receive |
|---|---|---|
| NXL104 | Experimental | Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104 Receives: Drug: NXL104 |
| Placebo | Placebo comparator | Three Japanese subjects to receive placebo IV doses Receives: Drug: Placebo |
| Ceftazidime NXL104 (CAZ104) | Experimental | Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime Receives: Drug: CAZ104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events will be monitored as a measure of safety and tolerability
Measured: A range of 12 days
Vital signs, physical examinations, clinical laboratory tests, 12 lead electrocardiogram (ECG) and digital ECG will be assessed as a measure of safety and tolerability
Measured: A range of 12 days
Secondary outcomes (3)
The pharmacokinetic parameters of plasma of NXL104 alone or in combination with ceftazidime
Measured: Range of 8 days
The pharmacokinetic parameters of urine of NXL104 alone or in combination with ceftazidime
Measured: Range of 8 days
The level of intestinal bacterial flora of NXL104 alone or in combination with ceftazidime
Measured: Range of 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
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 Healthy Male and Female Japanese VolunteersStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Newell, MD, Study director, AstraZenecaMark Yen, MD, Principal investigator, PAREXEL Early Phase/California Clinical Trials Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291602
- Sponsor's protocol ID
- D4280C00010
- Status last verified
- Aug 2017
- First submitted
- 6 Feb 2011
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
PubMed 30221827
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT01291602
- Acronym / sponsor ID
- D4280C00010
- Keywords
- NXL104, ceftazidime, CAZ104, Healthy Japanese volunteers, Phase 1, Single and Multiple Dose Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Feb 2011 (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.
This is a single and multiple dose study in healthy male and female (of non-childbearing potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NXL104 | Experimental | Drug: NXL104Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104 |
| Placebo | Placebo comparator | Drug: PlaceboThree Japanese subjects to receive placebo IV doses |
| Ceftazidime NXL104 (CAZ104) | Experimental | Drug: CAZ104Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- To be considered as 'Japanese', both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for more than 5 years
- Have a body mass index (BMI) between 17 and 27 kg/m2 inclusive and weigh at least 45 kg and no more than 100 kg.
- Females must not be lactating, and must be of non-childbearing potential (post-menopausal at least 12 months or documented irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
Key exclusion criteria (5 listed)
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- Symptoms of a clinically significant illness in the 3 months before the study
- History of hypersensitivity (eg, anaphylaxis), serious allergy, or any serious reaction to carbapenem, cephalosporins, or other β-lactam antibiotics
- Use within 14 days prior to the first study dose of any over-the-counter (including St. John's Wort or any herbal products) or prescription medication
- Smoker of more than 5 cigarettes/day or equivalent use of nicotine products during the previous 3 months
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 |
|---|---|---|
| NXL104IV Solution | Drug | NXL104 |
| CAZ104IV Solution | Drug | Ceftazidime NXL104 (CAZ104) |
| PlaceboIV saline | Drug | Placebo |
Primary outcome
Adverse events will be monitored as a measure of safety and tolerability
Time frame: A range of 12 days
Vital signs, physical examinations, clinical laboratory tests, 12 lead electrocardiogram (ECG) and digital ECG will be assessed as a measure of safety and tolerability
Time frame: A range of 12 days
3 secondary outcomes
The pharmacokinetic parameters of plasma of NXL104 alone or in combination with ceftazidime
Time frame: Range of 8 days
The pharmacokinetic parameters of urine of NXL104 alone or in combination with ceftazidime
Time frame: Range of 8 days
The level of intestinal bacterial flora of NXL104 alone or in combination with ceftazidime
Time frame: Range of 12 days
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 1 Sep 2017.
- Derived from this study: PubMed 30221827Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
- Study SynopsisLink 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.
Paul Newell, MD study director
AstraZeneca
Mark Yen, MD principal investigator
PAREXEL Early Phase/California Clinical Trials Medical Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NXL104 and CAZ104 in people with Healthy Male and Female Japanese Volunteers, run by Pfizer at 2 sites in United States.
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 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 1 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 2 sites in United States. 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?
Adverse events will be monitored as a measure of safety and tolerability (time frame: A range of 12 days). The study lists 2 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 NCT01291602, 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 1 Sep 2017.