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Renal Impairment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863161
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Reflux Renal Excretion Drug: AZD3355 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : March 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: 1
AZD3355 65 + 65 mg capsule
Drug: AZD3355
capsule, oral, single dose
Other Name: Lesogaberan




Primary Outcome Measures :
  1. Pharmacokinetic blood samples [ Time Frame: 15 samples during 0-72 hours ]

Secondary Outcome Measures :
  1. Pharmacokinetic urine samples [ Time Frame: 8 samples during 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863161


Locations
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Sweden
Research Site
Linkoping, Sweden
Research Site
Lulea, Sweden
Research
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Wolfgang Kuhn, MD Quintiles AB, Phase I Services, Strandbodgatan 1, 753 23 Uppsala, Sweden
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Responsible Party: Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00863161    
Other Study ID Numbers: D9120C00022
EudraCTnr 2008-007471-25
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
Safety
tolerability
exposure
healthy
renally impaired subjects
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Lesogaberan
Gastrointestinal Agents
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs