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Completed

NCT Number: NCT00715702

Safety Study of AZD5672 in Renally Impaired Subjects

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

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

München, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AZD5672

Drug

100 mg oral single dose

Primary outcomes

  1. PK variables

    Time frame: Frequent sampling occasions during study period

Secondary outcomes

  1. Safety variables (adverse events, blood pressure, pulse, safety lab)

    Time frame: During the treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-Label, Single-Centre, Parallel Group, Phase I Study To Compare the Pharmacokinetics of AZD5672 Single Dose in Patients With Renal Impairment and Healthy Volunteers

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2008
Registry last updated
Apr 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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