Safety Study of AZD5672 in Renally Impaired Subjects

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00715702

Collaborator

(none)

Enrollment

Location

Arms

7.1

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672 in patients with renal impairment by comparing with healthy volunteers

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment	Drug: AZD5672	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-Label, Single-Centre, Parallel Group, Phase I Study To Compare the Pharmacokinetics of AZD5672 Single Dose in Patients With Renal Impairment and Healthy Volunteers

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Patients with Moderate renal impairment and matched volunteers	Drug: AZD5672 100 mg oral single dose
Experimental: 2 Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data	Drug: AZD5672 100 mg oral single dose

Arm

Intervention/Treatment

Experimental: 1

Patients with Moderate renal impairment and matched volunteers

Drug: AZD5672

100 mg oral single dose

Experimental: 2

Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data

Drug: AZD5672

100 mg oral single dose

Outcome Measures

Primary Outcome Measures

PK variables [Frequent sampling occasions during study period]

Secondary Outcome Measures

Safety variables (adverse events, blood pressure, pulse, safety lab) [During the treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Provision of signed written informed consent.
Females should not be of childbearing potential
Subjects classified as renally impaired should have been stable (in the Investigator's opinion) for at least 3 months prior to Visit 1.

Exclusion Criteria:

Patients taking prescription of medications: Pgp substrates, inhibitors and /or inducers, medications that affect creatinine clearance(within 7 days of dosing), atorvastatin >20mg once daily, medications that prolong QT/QTc interval
Change in dose regimen of prescribed medication and NSAIDs within the 2 weeks before enrolment (renal patients only)
Participation in another clinical study involving administration of an investigational product in the 3 months prior to treatment (or within 5 half-lives of the last dose of the investigational product, whichever is longer)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	München		Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Rod Hepburn, AstraZeneca R&D, Charnwood, UK
Principal Investigator: Angelika Weil, APEX GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00715702

Other Study ID Numbers:

D1710C00020
EudraCt nr 2007-007541-

First Posted:

Jul 15, 2008

Last Update Posted:

Apr 29, 2009

Last Verified:

Apr 1, 2009

Keywords provided by , ,

AZD5672

Additional relevant MeSH terms:

Renal Insufficiency

N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide

Study Results

No Results Posted as of Apr 29, 2009