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Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects

NCT ID: NCT01154634

Last Updated: 2012-08-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.

Detailed Description

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A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers.

Conditions

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Reflux

Keywords

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Pharmacodynamic effect Reflux inhibition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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First 5 mg, then placebo, then 16 mg, then 40 mg

period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg.

Group Type EXPERIMENTAL

AZD2516, 5 mg

Intervention Type DRUG

Capsule, oral

AZD2516, 16 mg

Intervention Type DRUG

Capsule, oral

AZD2516, 40 mg

Intervention Type DRUG

Capsule, oral

Placebo

Intervention Type DRUG

Capsule, oral

First 40 mg, then 16 mg, then placebo, then 5 mg

period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg.

Group Type EXPERIMENTAL

AZD2516, 5 mg

Intervention Type DRUG

Capsule, oral

AZD2516, 16 mg

Intervention Type DRUG

Capsule, oral

AZD2516, 40 mg

Intervention Type DRUG

Capsule, oral

Placebo

Intervention Type DRUG

Capsule, oral

First 16 mg, then 5 mg, then 40 mg, then placebo

period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo.

Group Type EXPERIMENTAL

AZD2516, 5 mg

Intervention Type DRUG

Capsule, oral

AZD2516, 16 mg

Intervention Type DRUG

Capsule, oral

AZD2516, 40 mg

Intervention Type DRUG

Capsule, oral

Placebo

Intervention Type DRUG

Capsule, oral

First placebo, then 40 mg, then 5 mg, then 16 mg

period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg

Group Type EXPERIMENTAL

AZD2516, 5 mg

Intervention Type DRUG

Capsule, oral

AZD2516, 16 mg

Intervention Type DRUG

Capsule, oral

AZD2516, 40 mg

Intervention Type DRUG

Capsule, oral

Placebo

Intervention Type DRUG

Capsule, oral

Interventions

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AZD2516, 5 mg

Capsule, oral

Intervention Type DRUG

AZD2516, 16 mg

Capsule, oral

Intervention Type DRUG

AZD2516, 40 mg

Capsule, oral

Intervention Type DRUG

Placebo

Capsule, oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed informed consent
* Healthy male subjects
* Age 18-45 years, inclusive

Exclusion Criteria

* Clinically significant illness within the 2 weeks prior to the first dose of study drug
* History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease
* Need for concomitant medications during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Berner Hansen

Role: STUDY_DIRECTOR

AstraZeneca R&D Molndal

Locations

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Research Site

Leuven, , Belgium

Site Status

Research Site

Amsterdam, , Netherlands

Site Status

Countries

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Belgium Netherlands

Other Identifiers

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D3830C00001

Identifier Type: -

Identifier Source: org_study_id