A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin

April 28, 2011 updated by: AstraZeneca

A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily Via Tablet) for Eight Days and Single Doses of Pravastatin (Pravachol® Tablet 40 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Pravastatin in Healthy Male Volunteers

The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers aged 18 to 55, inclusive
  • Have a body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg, inclusive
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening
  • Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study

Exclusion Criteria:

  • Any clinically significant disease or disorder
  • Any clinically relevant abnormal findings in physical examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: AZD1981
100 mg per oral, twice daily for 8 days
Drug: AZD1981
4x100 mg per oral, twice daily for 8 days
Drug: pravastatin
40 mg, once daily at Day 1, period A and Day 8, period B
Other Names:
  • pravachol
Experimental: B
Drug: AZD1981
100 mg per oral, twice daily for 8 days
Drug: AZD1981
4x100 mg per oral, twice daily for 8 days
Drug: pravastatin
40 mg, once daily at Day 1, period A and Day 8, period B
Other Names:
  • pravachol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics for pravastatin measured by Cmax and AUC
Time Frame: Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B
Pharmacokinetics for pravastatin measured by Cmax and AUC
Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: PK sampling will be performed on Day 1, period A and on Day 7-8, period B
Pharmacokinetics for pravastatin measured by AUC[0-t],Cmax (tmax), CL/F, t1/2λz, Vz/F, MRT
PK sampling will be performed on Day 1, period A and on Day 7-8, period B
AUCτ
Time Frame: PK sampling will be performed on Day 7 and Day 8, period B
Pharmacokinetics for AZD1981 measured by AUCτ,Css,max, Css, max (tmax ss), CLss/F, t1/2λz, Vz/F, MRT
PK sampling will be performed on Day 7 and Day 8, period B
Safety and tolerability
Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
Safety and tolerability of AZD1981
Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (Estimate)

December 6, 2010

Study Record Updates

Last Update Posted (Estimate)

April 29, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9830C00016
  • 2010-023876-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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