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OpenTrials
Completed

NCT Number: NCT00733265

Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140.

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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, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients must have severe kidney disease
  • Subjects who are matched to the kidney disease patients in terms of weight, age, and sex must have normal kidneys
  • All women must be post-menopausal (no longer menstruating) or surgically sterile

Exclusion criteria

  • Patients requiring dialysis
  • History of allergy to aspirin or clopidogrel
  • Have increased bleeding risk (for instance uncontrolled high blood pressure or a recent major injury)
  • Recent history of fainting or light-headedness

Treatment and study plan

AZD6140

Drug

single oral dose

Primary outcomes

  1. Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys

    Time frame: Scheduled times during the 3 days after the study drug is taken

Secondary outcomes

  1. Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys

    Time frame: Screening through completion of the study

  2. Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys

    Time frame: Scheduled times during the 3 days after the study drug is taken

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2008
Registry last updated
Dec 3, 2010

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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