Renal Impairment Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00863161

Enrollment

Registered

2009-03-17

Start date

2009-03-31

Completion date

2010-02-28

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux, Renal Excretion

Keywords

Safety, tolerability, exposure, healthy, renally impaired subjects

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.

Interventions

DRUGAZD3355

capsule, oral, single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic blood samples	15 samples during 0-72 hours

Secondary

Measure	Time frame
Pharmacokinetic urine samples	8 samples during 72 hours

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026