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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

Phase 1
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Registration Number
NCT01083238
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
1AZD5069AZD5069 following a 10-hour fast
2AZD5069AZD5069 30 minutes after the start of a high fat meal
Primary Outcome Measures
NameTimeMethod
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).0 - 72 hours postdose
Secondary Outcome Measures
NameTimeMethod
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 temperaturevarious timepoints throughout the study from predose to follow-up

Trial Locations

Locations (1)

Research Site

🇬🇧

London, United Kingdom

Research Site
🇬🇧London, United Kingdom

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