A study to assess the pharmacokinetics of ceftaroline in end stage renal disease patients and matched healthy subjects

Study identifier:D3720C00012

ClinicalTrials.gov identifier:NCT01664065

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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)

Medical condition

Renal disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

200 mg Ceftaroline fosamil, 600 mg Ceftaroline fosamil

Sex

All

Actual Enrollment

15

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 01 Feb 2013
Primary Completion Date: 01 Nov 2013
Study Completion Date: 01 Nov 2013

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Feb 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria