Drug Interaction Study - Assess Pharmacokinetics of Both AZD5672 and Atorvastatin

NCT00722956 | Completed Phase 1

• 2 other identifiers: D1710C00025EudraCt nr 2008-001725-33
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the pharmacokinetics of both AZD5672 (steady-state) and atorvastatin (single dose) when co administered in healthy volunteers

Conditions

Healthy Volunteers; Pharmacokinetics

Keywords

atorvastatin; AZD5672

Outcome Measures

Primary Outcomes (1)

• PK variables

  Frequent sampling occasions during study periods

Secondary Outcomes (1)

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

  During the whole treatment periods

Study Arms (1)

1

EXPERIMENTAL

AZD5672 + atorvastatin

Drug: AZD5672; Drug: atorvastatin

Interventions

AZD5672 DRUG

100 mg once daily, 10 days

1

atorvastatin DRUG

one single dose of 40 mg on day 10

Also known as: Lipitor®

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of informed consent prior to any study specific procedures.
• Females should not be of childbearing potential
• Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results

You may not qualify if:

• Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
• Known allergy to atorvastatin (or other statins) or previous complications to atorvastatin therapy.
• Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Rod Hepburn

  AstraZeneca R&D, Charnwood, UK

  STUDY DIRECTOR

• Maura Fallon

  PAREXEL Clinical Pharmacology Research Unit

  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 24, 2008
• First Posted: July 28, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 2, 2010

Record last verified: 2010-11

Locations

GB (1)