Safety Study of AZD5672 in Renally Impaired Subjects

NCT00715702 | Completed Phase 1

• 2 other identifiers: D1710C00020EudraCt nr 2007-007541-
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Impairment

Keywords

AZD5672

Outcome Measures

Primary Outcomes (1)

• PK variables

  Frequent sampling occasions during study period

Secondary Outcomes (1)

• Safety variables (adverse events, blood pressure, pulse, safety lab)

  During the treatment period

Study Arms (2)

1

EXPERIMENTAL

Patients with Moderate renal impairment and matched volunteers

Drug: AZD5672

2

EXPERIMENTAL

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

Drug: AZD5672

Interventions

AZD5672 DRUG

100 mg oral single dose

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

München, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

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

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Rod Hepburn

  AstraZeneca R&D, Charnwood, UK

  STUDY DIRECTOR

• Angelika Weil

  APEX GmbH

  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: July 11, 2008
• First Posted: July 15, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 29, 2009

Record last verified: 2009-04

Locations

DE (1)