NCT01624246

Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance

A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).

Detailed description

To evaluate the single-dose pharmacokinetic (PK) profiles of ceftaroline and avibactam following intravenous (IV) administration of ceftaroline fosamil/avibactam ("CXL") in adults with augmented renal clearance (ARC).

Conditions

• Augmented Renal Clearance (ARC)
• Systemic Inflammatory Response Syndrome (SIRS)

Interventions

Type	Name	Description
DRUG	Ceftaroline fosamil/Avibactam (CXL)	IV infusion of CXL (combination of ceftaroline fosamil \[600 mg\] plus avibactam \[600 mg\]) infused over 60 (± 5) minutes.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-06-20
• Last updated: 2017-04-07

Locations

21 sites across 2 countries: United States, Australia