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A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days

NCT ID: NCT01116258

Last Updated: 2010-10-11

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

AZD5847

Intervention Type DRUG

oral suspension, 15 days

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral suspension, 15 days

Interventions

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AZD5847

oral suspension, 15 days

Intervention Type DRUG

Placebo

oral suspension, 15 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI between 18-30

Exclusion Criteria

* Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes
* History of presence of gastrointestinal, hepatic or renal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Andrew Shaw

Role: STUDY_DIRECTOR

AstraZeneca

Brendan Smyth

Role: STUDY_CHAIR

AstraZeneca

David Melnick

Role: STUDY_DIRECTOR

AstraZeneca

Eleanor Lisbon

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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D3430C00002

Identifier Type: -

Identifier Source: org_study_id