Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

NCT01648127 | Completed Phase 1

• 1 other identifier: TEF-MD-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Safety

Keywords

Ceftaroline; Pharmacokinetics; Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To evaluate the safety and tolerability of intravenous ceftaroline

  24 hours

Study Arms (1)

Ceftaroline

EXPERIMENTAL

Ceftaroline intravenous 600 mg single dose

Drug: Ceftaroline

Interventions

Ceftaroline DRUG

A single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion

Also known as: Teflaro

Ceftaroline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adult subjects
• nonsmokers within the last 1 year
• body mass index and total body weight within specific categories

You may not qualify if:

• history of significant hypersensitivity reaction or intolerance to ceftaroline or beta-lactam agents or heparin
• aspartate or alanine aminotransferase \>3 times the upper limit of normal
• estimated creatinine clearance \<60 mL/minute and serum creatinine \>1.5 mg/dL
• female subjects who are pregnant or breast feeding
• history of alcohol or substance abuse or dependence within the last 1 year
• use of prescription or nonprescription drugs within last 7 to 14 days
• participations in a clinical trials within last 30 days
• donated blood (\>500 mL) within the last 56 days

Sponsors & Collaborators

• Keith A. Rodvold: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 25896707 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Ceftaroline

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Keith A Rodvold, Pharm.D.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 24, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 14, 2013

Record last verified: 2013-03

Locations

US (1)