A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched Healthy Subjects

Pfizer

Status and phase

Completed

Phase 1

Conditions

Renal Disease

Treatments

Drug: 200 mg Ceftaroline fosamil

Drug: 600 mg Ceftaroline fosamil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01664065

D3720C00012

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of Ceftaroline in a group of patients with renal disease and matching healthy subjects with normal renal function

Full description

An Open-label, Nonrandomised, Phase I Study to Assess the Pharmacokinetics of Ceftaroline After Intravenous Administration of aSingle Dose of Ceftaroline Fosamil (200 mg) to Patients with End-stage Renal Disease Undergoing Haemodialysis when Compared to a Single Dose of Ceftaroline Fosamil (600 mg)

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Provision of signed and dated, written informed consent prior to any study specific procedures
Male and female subjects aged 18 to 75 years (inclusive) with suitable veins for cannulation or repeated venipuncture
Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 3 months prior to enrollment, during the study, and for 3 months after completion of all study-related proceed
Have a body mass index (BMI) between 18 and 35 kg/m2 and weigh at between 50 and 110 kg
Haematocrit level higher than 30% at screening and baseline for each treatment period

Exclusion criteria

History or presence of gastrointestinal, hepatic, or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator
Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG that may interfere with the interpretation of QTc interval changes
History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
Receiving any dialysis treatment other than intermittent haemodialysis