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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: AZD5069

Study type

Interventional

Funder types

Industry

Identifiers

NCT01083238
D3550C00010

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups

1
Experimental group
Description:
AZD5069 following a 10-hour fast
Treatment:
Drug: AZD5069
2
Experimental group
Description:
AZD5069 30 minutes after the start of a high fat meal
Treatment:
Drug: AZD5069

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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