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

NCT01083238 | Completed Phase 1

• 1 other identifier: D3550C00010
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

AZD5069 following a 10-hour fast

Drug: AZD5069

2

EXPERIMENTAL

AZD5069 30 minutes after the start of a high fat meal

Drug: AZD5069

Interventions

AZD5069 DRUG

120mg single oral dose

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Research Site

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29856004 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Fasting

Interventions

N-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Darren Wilbraham, MBBS DCPSA

  Quintiles Drug Research Unit at Guy's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: March 9, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

GB (1)