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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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

AZD5069

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring pharmacokinetics, fasting or after a high fat meal, adult, elderly adult, COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

AZD5069 following a 10-hour fast

AZD5069 30 minutes after the start of a high fat meal

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01083238

First Posted

February 22, 2010

Last Updated

June 24, 2015

Sponsor

AstraZeneca

Collaborators

Quintiles, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01083238

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Quintiles, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

pharmacokinetics, fasting or after a high fat meal, adult, elderly adult, COPD

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AZD5069 following a 10-hour fast

Arm Title

Arm Type

Experimental

Arm Description

AZD5069 30 minutes after the start of a high fat meal

Intervention Type

Drug

Intervention Name(s)

AZD5069

Intervention Description

120mg single oral dose

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

various timepoints throughout the study from predose to follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Darren Wilbraham, MBBS DCPSA

Organizational Affiliation

Quintiles Drug Research Unit at Guy's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29856004

Citation

Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1338&filename=D3550C00010_Study_Synopsis.pdf

Description

CSR Synopsis

Learn more about this trial

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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