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This is a single dose study in healthy male volunteers to investigate the effect of high doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CXL104 | Experimental | 2000 mg NXL104 + 1500 mg Ceftaroline (IV) |
|
| CAZ104 | Experimental | Placebo Infusion (saline) + 2000 mg NXL104 + 3000 mg Ceftazidime (IV) |
|
| Moxifloxacin | Active Comparator | Moxifloxacin 400mg (1 tablet) |
|
| Placebo | Placebo Comparator | Placebo Infusion (saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXL104 | Drug | IV Solution |
| |
| Ceftaroline |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). | 12-lead dECG will be performed pre-dose | |
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). | 12-lead dECG at 30 min after starting dosing. | |
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). | 12-lead dECG at 60 min after starting dosing. | |
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). | 12-lead dECG at 90 min after starting dosing. | |
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). | 12-lead dECG at 2 hour after starting dosing. | |
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). | 12-lead dECG at 3 hour after starting dosing. | |
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). | 12-lead dECG at 4 hour after starting dosing. | |
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). | 12-lead dECG will be performed pre-dose | |
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Newell, MD | AstraZeneca | Study Director |
| David Mathews, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24150927 | Derived | Das S, Armstrong J, Mathews D, Li J, Edeki T. Randomized, placebo-controlled study to assess the impact on QT/QTc interval of supratherapeutic doses of ceftazidime-avibactam or ceftaroline fosamil-avibactam. J Clin Pharmacol. 2014 Mar;54(3):331-40. doi: 10.1002/jcph.199. Epub 2013 Oct 22. |
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| Drug |
IV Solution |
|
| Placebo Infusion | Drug | IV Saline |
|
| Ceftazidime | Drug | IV Solution |
|
| Moxifloxacin | Drug | Tablet (1) |
|
| 12-lead dECG at 6 hour after starting dosing. |
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). | 12-lead dECG at 8 hour after starting dosing. |
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). | 12-lead dECG at 12 hour after starting dosing. |
| To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF). | 12-lead dECG at 24 hour after starting dosing. |
| 12-lead dECG at 30 min after starting dosing. |
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). | 12-lead dECG at 60 min after starting dosing. |
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). | 12-lead dECG at 90 min after starting dosing. |
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). | 12-lead dECG at 2 hour after starting dosing. |
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). | 12-lead dECG at 3 hour after starting dosing. |
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). | 12-lead dECG at 4 hour after starting dosing. |
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). | 12-lead dECG at 6 hour after starting dosing. |
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). | 12-lead dECG at 8 hour after starting dosing. |
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). | 12-lead dECG at 12 hour after starting dosing. |
| To investigate the effect of CAZ104 and CXL104, on additional ECG variables (heart rate, RR, PR, QRS, QT, and QTcB). | 12-lead dECG at 24 hour after starting dosing. |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken pre-dose |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 30 min after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 60 min after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 75 min after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 90 min after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 2 hour after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 3 hour after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 4 hour after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 6 hour after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 8 hour after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 12 hour after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 18 hour after starting dosing |
| To assess the PK of NXL104, ceftaroline, ceftazidime and moxifloxacin by determination where applicable of Cmax, tmax, AUC(0-t), AUC, t½, CL, CL/F, Vss, and Vz/F. | Blood samples will be taken at 24 hour after starting dosing. |
| ID | Term |
|---|---|
| C543519 | avibactam |
| D000097583 | Ceftaroline |
| D002442 | Ceftazidime |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002509 | Cephaloridine |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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