Drug Interaction Study - Assess Pharmacokinetics of Both AZD5672 and Atorvastatin

Healthy Volunteers Clinical Trial

Official title:

A Phase I, Single Centre, Open-label Study to Assess the Pharmacokinetics of Both AZD5672 (Steady-state) and Atorvastatin (Single Dose) When Co Administered in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722956
• Other study ID #: D1710C00025
• Secondary ID: EudraCt nr 2008-
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2008
• Last updated: November 30, 2010
• Start date: July 2008
• Est. completion date: August 2008

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacokinetics

Intervention

Drug:
• AZD5672
100 mg once daily, 10 days
• atorvastatin
one single dose of 40 mg on day 10

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Frequent sampling occasions during study periods	No
Secondary	Safety variables (adverse events, blood pressure, pulse, safety lab)		During the whole treatment periods	Yes