A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been terminated.
(temporary hold in May 2010 due to an emerging PK profile that could not be aligned to the known pharmaceutical properties of the IMP (AZD6553).)
Sponsor:
Collaborator:
Quintiles
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01068184
First received: February 11, 2010
Last updated: September 22, 2010
Last verified: September 2010
  Purpose

AZD6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become inflamed and the small airsacs of the lungs become damaged. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of airflow is poorly reversible and usually gets progressively worse over time. There is an urgent medical need for therapies that could slow disease progression by targeting the underlying mechanisms associated with the changes in the lungs in patients with COPD. AZD6553 acts by reducing the activity of a protease found to be involved in the disease process in COPD. AZD6553 is being developed as a novel oral treatment to control the symptoms and exacerbations of COPD, and reduce the progression and severity of the disease. The purpose of this research study is to determine how safe and well-tolerated AZD6553 is and how much AZD6553 enters blood circulation by collecting blood and urine samples during the study. We are also investigating what AZD6553 is broken down into, when given orally, how much of the drug is cleared from the body via the kidneys, and the effect of taking the drug after food. This will all be done by analysis of blood and urine samples taken at various point during the study.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: AZD6553
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, 3-Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of AZD6553 in Healthy Volunteers (Parts A and B) and Patients (Part C) With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (adverse events, ECG's blood pressure, pulse, safety lab) [ Time Frame: Part A Intensive sampling for 24 hours , frequent sampling up to 72 hours, Part B Frequent Sampling over 12 days with intensive sampling on Days 1-2 and 8-9 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic variables:-Cmax, AUC, tmax and t1/2 [ Time Frame: Part A Intensive sampling for 24 hours , frequent sampling up to 72 hours, Part B Frequent Sampling over 12 days with intensive sampling on Days 1-2 and 8-9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung Function SVC, IC, FEV1, FVC [ Time Frame: Part C Days 2, 7 and 14 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic variables; Urine CLR [ Time Frame: Part A Days 1 and 2, Part B, Days 1 and 2 and Days 8,9 and 10, and Part C Day 1 and Day 14 ] [ Designated as safety issue: No ]

Estimated Enrollment: 109
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD6553
Single or multiple oral dose
Placebo Comparator: 2 Drug: Placebo
single or multiple oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parts A and B only; Body mass index (BMI) between 18 and 30 kg/m2.
  • Parts A and B only; Normal physical examination, laboratory values, and vital signs (blood pressure and pulse) unless the investigator considers an abnormality to be clinically irrelevant.
  • Part C only; clinical diagnosis of COPD for at least one year and Post-bronchodilator FEV1 30 - 80% predicted, FEV1/FVC ratio < 70%

Exclusion Criteria:

  • Participation in any clinical study with an investigational drug or new formulation of a marketed drug in the 3 months prior to Visit 2, or participation in a method development study one month prior to Visit 1
  • Part C only: An acute exacerbation or acute respiratory infection (upper or lower) in the 4 weeks prior to Visit 1 or Visit 2.
  • Part C only: Concomitant diagnosis of significant pulmonary disease other than COPD, including symptomatic asthma, cystic fibrosis and allergic bronchopulmonary aspergillosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068184

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Quintiles
Investigators
Principal Investigator: T G K Mant, FRCP (UK) FFPM Quintiles Drug Research Unit at Guy's Hospital
Study Director: Joanna Marks-Konczalik AstraZeneca R&D Charnwood
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01068184     History of Changes
Other Study ID Numbers: D2580C00001, 2009-016931-36
Study First Received: February 11, 2010
Last Updated: September 22, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
AZD6553
Chronic
obstructive
pulmonary
lung
respiratory disease
placebo-controlled
COPD
Healthy Volunteers
COPD Patients

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014