Safety Study of AZD5672 in Renally Impaired Subjects

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AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Renal Impairment

Treatments

Drug: AZD5672

Study type

Interventional

Funder types

Industry

Identifiers

NCT00715702
EudraCt nr 2007-007541-
D1710C00020

Details and patient eligibility

About

The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672 in patients with renal impairment by comparing with healthy volunteers

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Provision of signed written informed consent.
  • Females should not be of childbearing potential
  • Subjects classified as renally impaired should have been stable (in the Investigator's opinion) for at least 3 months prior to Visit 1.

Exclusion criteria

  • Patients taking prescription of medications: Pgp substrates, inhibitors and /or inducers, medications that affect creatinine clearance(within 7 days of dosing), atorvastatin >20mg once daily, medications that prolong QT/QTc interval
  • Change in dose regimen of prescribed medication and NSAIDs within the 2 weeks before enrolment (renal patients only)
  • Participation in another clinical study involving administration of an investigational product in the 3 months prior to treatment (or within 5 half-lives of the last dose of the investigational product, whichever is longer)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 2 patient groups

1
Experimental group
Description:
Patients with Moderate renal impairment and matched volunteers
Treatment:
Drug: AZD5672
2
Experimental group
Description:
Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data
Treatment:
Drug: AZD5672

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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