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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01083238
First received: February 22, 2010
Last updated: September 16, 2010
Last verified: September 2010

February 22, 2010
September 16, 2010
February 2010
July 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01083238 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
This Study Will Investigate How Food and Age Effect the Way the Body Handles the AZD5069 Drug Given as a Oral Dose
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)

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Chronic Obstructive Pulmonary Disease
Drug: AZD5069
120mg single oral dose
  • Experimental: 1
    AZD5069 following a 10-hour fast
    Intervention: Drug: AZD5069
  • Experimental: 2
    AZD5069 30 minutes after the start of a high fat meal
    Intervention: Drug: AZD5069
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01083238
D3550C00010
No
MSD, AstraZeneca
AstraZeneca
Quintiles
Principal Investigator: Darren Wilbraham, MBBS DCPSA Quintiles Drug Research Unit at Guy's Hospital
AstraZeneca
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP