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This is an open-label study divided in 2 parts and 3 cohorts to determine the concentration of Avibactam and Ceftazidime in the lining of the lungs and the blood.
A Phase I Open-Label, 2-Part, 3-Cohort, Single-Centre Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma Using at Least Two Different Dosing Regimens in Healthy Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CAZ104 (2000mg Ceftazidime/500mg Avibactam) |
|
| 2 | Experimental | CAZ104 (3000mg Ceftazidime/1000mg Avibactam) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAZ104 | Drug | IV Infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure and compare the concentration of Avibactam and Ceftazidime in ELF and plasma | To measure and compare the concentration of Avibactam and Ceftazidime in ELF and plasma by assessment of maximum concentration (Cmax), time to Cmax (tmax), area under the concentration time curve during a dosing interval t (AUCτ), terminal half life (t½λz) in plasma and ELF, plasma clearance (CL), volume of distribution at steady state (Vss) and at the terminal phase (Vz) in plasma, ratio of Cmax in ELF over Cmax in plasma and ratio of AUCτ in ELF over AUCτ in plasma. | at several timepoints from pre-dose up to 5 days post dose (Part 2) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety and tolerability of Avibactam and Ceftazidime | To evaluate safety and tolerability of Avibactam and Ceftazidime by assessment of adverse events (AEs), physical examinations, vital signs, 12 lead electrocardiograms (ECGs), Pulse oximetry and safety laboratory assessments | at several timepoints from pre-dose up to 5 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Newell, MD | AstraZeneca | Study Director |
| Leonard Siew, MBCHB, MRCP(UK) | Quintiles Phase I unit London | Principal Investigator |
| Mirjana Kujacic, MD | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26133566 | Background | Nicolau DP, Siew L, Armstrong J, Li J, Edeki T, Learoyd M, Das S. Phase 1 study assessing the steady-state concentration of ceftazidime and avibactam in plasma and epithelial lining fluid following two dosing regimens. J Antimicrob Chemother. 2015 Oct;70(10):2862-9. doi: 10.1093/jac/dkv170. Epub 2015 Jul 1. |
| Label | URL |
|---|---|
| Clinical Study Protocol | View source |
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| ID | Term |
|---|---|
| D002442 | Ceftazidime |
| C543519 | avibactam |
| ID | Term |
|---|---|
| D002509 | Cephaloridine |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
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| CAZ104 | Drug | IV Infusion |
|
|
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |