This Study Will Investigate How Food and Age Effect the Way the Body Handles the AZD5069 Drug Given as a Oral Dose

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-07-31

Brief Summary

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AZD5069 is a new drug being tested for the possible treatment of people with chronic obstructive pulmonary disease (COPD).

This is not the first time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females in fed and fasted states. We will compare the way the body handles this drug in the fed and fasted states, in subjects in the age group of 18 to 65 years. We will compare the way the body handles this drug between the age groups of 18 to 65 years and above 65 years. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

AZD5069 following a 10-hour fast

Group Type EXPERIMENTAL

AZD5069

Intervention Type DRUG

120mg single oral dose

2

AZD5069 30 minutes after the start of a high fat meal

Group Type EXPERIMENTAL

AZD5069

Intervention Type DRUG

120mg single oral dose

Interventions

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AZD5069

120mg single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria

* Has participated in another clinical study and received drug treatment within 3 months of the first administration of drug in this study.
* Subjects with a past medical history of tuberculosis (TB).
* Subjects with latent or chronic infections

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes