A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)
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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 |
- 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 ]
- 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 |
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| United Kingdom | |
| Research Site | |
| London, United Kingdom | |
| 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 13, 2013