Renal Impairment Study

Reflux Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863161
• Other study ID #: D9120C00022
• Secondary ID: EudraCTnr 2008-0
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2009
• Last updated: January 21, 2011
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Reflux
• Renal Excretion
• Renal Insufficiency

Intervention

Drug:
• AZD3355
capsule, oral, single dose

Locations

Country	Name	City	State
Sweden	Research Site	Linkoping
Sweden	Research Site	Lulea
Sweden	Research	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic blood samples		15 samples during 0-72 hours	No
Secondary	Pharmacokinetic urine samples		8 samples during 72 hours	No