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Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male Subjects

NCT ID: NCT00984477

Last Updated: 2009-12-04

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-11-30

Brief Summary

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The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by the body when given to healthy, non smoking males at different dose levels. This is a 2 part study, in Part B a single group of subjects will be given both an oral dose and intravenous microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy volunteer healthy subjects AZD5122 single oral dose phase 1 Healthy volunteer phase 1 study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

AZD5122 oral suspension (part A and B)

Group Type EXPERIMENTAL

AZD5122

Intervention Type DRUG

A single dose of oral suspension

2

Placebo oral suspension (part A)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A single dose of oral suspension

3

AZD5122 oral and IV infusion (part B)

Group Type EXPERIMENTAL

AZD5122

Intervention Type DRUG

A single dose of oral suspension

AZD5122

Intervention Type DRUG

A single intravenous infusion

Interventions

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AZD5122

A single dose of oral suspension

Intervention Type DRUG

Placebo

A single dose of oral suspension

Intervention Type DRUG

AZD5122

A single intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent.
* Normal physical examination, laboratory values, blood pressure and pulse
* Healthy male caucasian subjects

Exclusion Criteria

* Subjects must not have any history of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body.
* Subjects must not have abnormal blood or urine tests for hsCRP, circulating neutrophils, haematocrit, haemoglobin or renal function
* Subjects must not have crystals or more than a trace of blood in their urine
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Principal Investigators

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Andrew Sparrow, BSc, BMedSci, BM,BS

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH

Locations

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Research Site

Nottinghamshire, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D2650C00006

Identifier Type: -

Identifier Source: org_study_id