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

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083238
• Other study ID #: D3550C00010
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2010
• Last updated: June 24, 2015
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: June 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD5069
120mg single oral dose

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Quintiles, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes

External Links

•   CSR Synopsis