Status:
COMPLETED
To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients
Lead Sponsor:
AstraZeneca
Conditions:
COPD
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic obstructive pulmonary d...
Detailed Description
A Phase I, Randomized, DoubleBlind Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Inhaled Doses (MAD) of AZD7624 to Healthy Subjects and Pa...
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Plasma myoglobin and CK not above the upper reference range of the analysing laboratory at Day -1
- Male and/or female patients with COPD aged above18 years with suitable veins for cannulation or repeated venipuncture.
- Clinical diagnosis of COPD for more than 1 year at Visit 1, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Exclusion
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IP
- Receipt of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that included drug treatment within at least 3 months of the first administration of the IP in this study
- Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV)
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01817855
Start Date
September 1 2013
End Date
October 1 2014
Last Update
March 30 2016
Active Locations (1)
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1
Research Site
London, United Kingdom