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Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses ofAZD2551

NCT ID: NCT00860353

Last Updated: 2010-12-03

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-05-31

Brief Summary

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The purpose of this study is to determine how well tolerated and safe AZD2551 is at different dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is absorbed into and cleared by the body

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy Volunteer Single Ascending Dose Safety Tolerability AZD2551 Healthy Volunteer 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

Group Type EXPERIMENTAL

AZD2551

Intervention Type DRUG

Single dose of oral solution.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose of oral solution

Interventions

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AZD2551

Single dose of oral solution.

Intervention Type DRUG

Placebo

Single dose of oral solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Be willing to use barrier methods of contraception unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods
* Have a body mass index between 18 and 30 kg/m2 inclusive and weight at least 50kg and no more than 100kg

Exclusion Criteria

* Use of any prescribed or non-prescribed medication during the two weeks prior to the administration of study drug
* History or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
* Any impairment of kidney function or laboratory results for markers of kidney function that are outside the reference range and considered clinically significant
* Underlying musculoskeletal symptoms of unknown origin, subjects with shoulder girdle musculoskeletal symptoms or Dupuytrens syndrome
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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AstraZeneca Pharmaceuticals

Principal Investigators

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William Fahy, MA, MBBS (Hons)

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Research Site

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D1570C00001

Identifier Type: -

Identifier Source: org_study_id