NCT00863161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

11 months

First QC Date

March 16, 2009

Last Update Submit

January 21, 2011

Conditions

RefluxRenal Excretion

Keywords

Safetytolerabilityexposurehealthyrenally impaired subjects

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic blood samples

    15 samples during 0-72 hours

Secondary Outcomes (1)

  • Pharmacokinetic urine samples

    8 samples during 72 hours

Study Arms (1)

1

EXPERIMENTAL

AZD3355 65 + 65 mg capsule

Drug: AZD3355

Interventions

AZD3355DRUG

capsule, oral, single dose

Also known as: Lesogaberan
1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Linköping, Sweden

Location

Research Site

Luleå, Sweden

Location

Research

Uppsala, Sweden

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

lesogaberan

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Wolfgang Kuhn, MD

    Quintiles AB, Phase I Services, Strandbodgatan 1, 753 23 Uppsala, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

SE(3)