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Completed

NCT Number: NCT00863161

Renal Impairment Study

The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and leaves the blood in people with normal kidney function or with different degrees of reduced kidney function.

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Key information

Conditions

Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Renal Excretion

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Linköping, Sweden

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of signed informed consent
  • Subjects should have either normal renal function or have a moderate renal impairment or severe renal impairment

Exclusion criteria

  • History of heart disease
  • Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Treatment and study plan

AZD3355

Drug

capsule, oral, single dose

Other names: Lesogaberan

Primary outcomes

  1. Pharmacokinetic blood samples

    Time frame: 15 samples during 0-72 hours

Secondary outcomes

  1. Pharmacokinetic urine samples

    Time frame: 8 samples during 72 hours

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Open Label, Non-randomized, Parallel Group, Pharmacokinetic Study in Subjects With Normal Renal Function, Moderate or Severe Renal Impairment Receiving a Single Dose of Oral 130 mg AZD3355

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 17, 2009
Registry last updated
Jan 24, 2011

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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