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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

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ClinicalTrials.gov Identifier: NCT01083238
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : June 25, 2015
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: AZD5069 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I, Two-part Study to Investigate the Effects of Food on the PK, Safety and Tolerability of a Single Oral Dose of AZD5069 (120 mg) in Healthy Adult Volunteers (Part A) and to Compare the PK of AZD5069 in Adult and Elderly Healthy Volunteers (Part B)
Study Start Date : February 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: 1
AZD5069 following a 10-hour fast
Drug: AZD5069
120mg single oral dose

Experimental: 2
AZD5069 30 minutes after the start of a high fat meal
Drug: AZD5069
120mg single oral dose




Primary Outcome Measures :
  1. Pharmacokinetic blood to measure Maximum plasma concentration (Cmax); time to Cmax (tmax); and the area under the plasma concentration-time curve from zero to infinity (AUC). [ Time Frame: 0 - 72 hours postdose ]

Secondary Outcome Measures :
  1. Safety and tolerability of AZD5069 by assessing Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables (including high sensitivity C-reactive protein [hsCRP] and circulating neutrophils), blood pressure, pulse rate, body temperature [ Time Frame: various timepoints throughout the study from predose to follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083238


Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Quintiles, Inc.
Investigators
Principal Investigator: Darren Wilbraham, MBBS DCPSA Quintiles Drug Research Unit at Guy's Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01083238     History of Changes
Other Study ID Numbers: D3550C00010
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by AstraZeneca:
pharmacokinetics
fasting or after a high fat meal
adult
elderly adult
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases