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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NXL104 | Experimental | Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104 |
|
| Placebo | Placebo Comparator | Three Japanese subjects to receive placebo IV doses |
|
| Ceftazidime NXL104 (CAZ104) | Experimental | Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXL104 | Drug | IV Solution |
| |
| CAZ104 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events will be monitored as a measure of safety and tolerability | 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 | A range of 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic parameters of plasma of NXL104 alone or in combination with ceftazidime | Range of 8 days | |
| The pharmacokinetic parameters of urine of NXL104 alone or in combination with ceftazidime | Range of 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Newell, MD | AstraZeneca | Study Director |
| Mark Yen, MD | PAREXEL Early Phase/California Clinical Trials Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30221827 | Derived | 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. |
| Label | URL |
|---|---|
| Study Synopsis | View source |
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| Drug |
IV Solution |
|
| Placebo | Drug | IV saline |
|
| The level of intestinal bacterial flora of NXL104 alone or in combination with ceftazidime | Range of 12 days |
| Baltimore |
| Maryland |
| United States |
| ID | Term |
|---|---|
| C543519 | avibactam |
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