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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of this study is to characterize plasma and urinary concentrations of ceftaroline following intravenous administration of a single dose of ceftaroline 600 mg in healthy subjects who are normal weight, overweight, and obese.
This study is planned to be a Phase I, open-label, single period, single-dose pharmacokinetic study conducted in 32 healthy adult male and female subjects. Adult subjects will be recruited and assigned to one of four groups based on their body mass index and total body weight. Subject will receive a single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion. Serial blood and urine samples will be collected over the next 12 hours to determine serum and urinary pharmacokinetics of ceftaroline. Safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests (serum chemistry and hematology), pregnancy testing (female subjects only), monitoring of adverse events, and recording of concomitant medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftaroline | Experimental | Ceftaroline intravenous 600 mg single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftaroline | Drug | A single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ceftaroline following intravenous administration of a single 600 mg dose to healthy subjects | Plasma maximum serum concentration of ceftaroline Area-under-the-concentration-time curve of ceftaroline: Time frame Predose (time zero [0]) to 12 hours Total body clearance of ceftaroline Apparent volume of distribution of ceftaroline Elimination rate constant of ceftaroline Elimination half-life of ceftaroline Renal clearance of ceftaroline: Time frame Predose (time zero [0]) to 12 hours Amount of ceftaroline excreted in the urine: Time frame Predose (time zero [0]) to 12 hours | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of intravenous ceftaroline | Number of participants with adverse events Number of participants with changes in clinical laboratories Number of participants with changes in vital sign assessments | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith A Rodvold, Pharm.D. | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25896707 | Derived | Justo JA, Mayer SM, Pai MP, Soriano MM, Danziger LH, Novak RM, Rodvold KA. Pharmacokinetics of ceftaroline in normal body weight and obese (classes I, II, and III) healthy adult subjects. Antimicrob Agents Chemother. 2015 Jul;59(7):3956-65. doi: 10.1128/AAC.00498-15. Epub 2015 Apr 20. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |