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: Drug: AZD5069

• 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

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

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

Group	Intervention	Description
1	AZD5069	AZD5069 following a 10-hour fast
2	AZD5069	AZD5069 30 minutes after the start of a high fat meal

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	various timepoints throughout the study from predose to follow-up

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom