Renal Impairment Study

Phase 1

Completed

• Conditions: Reflux; Renal Excretion
• Interventions: Drug: AZD3355

• Registration Number: NCT00863161
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD3355	AZD3355 65 + 65 mg capsule

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic blood samples	15 samples during 0-72 hours

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic urine samples	8 samples during 72 hours

Trial Locations

Locations (2)

Research Site; 🇸🇪 Lulea, Sweden

Research; 🇸🇪 Uppsala, Sweden