To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients

NCT ID: NCT01817855

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-10-31

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 disease.

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 Patients with COPD

Conditions

COPD; Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1

Groups 1-4 multiple ascending doses of AZD7624 Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo.

COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 patients will receive matching placebo.

Group Type: EXPERIMENTAL

AZD7624

Intervention Type: DRUG

Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer

2

Groups 1-4 multiple ascending doses of placebo Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo.

COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 will receive matching placebo.

Group Type: PLACEBO_COMPARATOR

Placebo to match

Intervention Type: DRUG

Multiple doses inhaled placebo via a nebulizer

Interventions

AZD7624

Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer

Intervention Type: DRUG

Placebo to match

Multiple doses inhaled placebo via a nebulizer

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saeed Khan, MBBS, MRCP

Role: PRINCIPAL_INVESTIGATOR

Quintiles Drg Research Centre At Guys Hosipital, 6 Newcomen Street London SE1 1YR

Naimish Patel, MD

Role: STUDY_CHAIR

AstraZeneca, Wilmington, US

Locations

Research Site

London, , United Kingdom

Countries

United Kingdom

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1273&filename=D2550C00002_synopsis.pdf

CSR Synopsis

Other Identifiers

D2550C00002

Identifier Type: -

Identifier Source: org_study_id