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

NCT ID: NCT01254461

Last Updated: 2011-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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Conditions

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Drug Interaction

Keywords

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Phase 1 Drug-Drug interaction pravastatin AZD1981 The pharmacokinetics resulting from AZD1981 and pravastatin interaction The effects of taking a combination of AZD1981 and pravastatin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

100 mg per oral, twice daily for 8 days

pravastatin

Intervention Type DRUG

40 mg, once daily at Day 1, period A and Day 8, period B

B

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

4x100 mg per oral, twice daily for 8 days

pravastatin

Intervention Type DRUG

40 mg, once daily at Day 1, period A and Day 8, period B

Interventions

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AZD1981

100 mg per oral, twice daily for 8 days

Intervention Type DRUG

AZD1981

4x100 mg per oral, twice daily for 8 days

Intervention Type DRUG

pravastatin

40 mg, once daily at Day 1, period A and Day 8, period B

Intervention Type DRUG

Other Intervention Names

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pravachol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D

Locations

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Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2010-023876-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D9830C00016

Identifier Type: -

Identifier Source: org_study_id