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AZD8683 Multiple Dose Study in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT01584739

Last Updated: 2012-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-11-30

Brief Summary

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This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending inhaled doses of AZD8683 in Healthy volunteers and repeated inhalation of one dose level of AZD8683 in patients with chronic obstructive pulmonary disease given once daily.

Detailed Description

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A Phase I, Single Centre, Double-Blind, Randomised, Placebo- controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD8683 in Healthy Volunteers and COPD patients

Conditions

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COPD

Keywords

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Safety tolerability healthy COPD (chronic obstructive pulmonary disease) pharmacokinetic pharmacodynamic inhaled

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD8683

Group Type EXPERIMENTAL

AZD8683

Intervention Type DRUG

Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients)

Placebo to AZD8683

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients

Interventions

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AZD8683

Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients)

Intervention Type DRUG

Placebo

Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers and healthy female volunteers of non-child bearing potential, aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture - Healthy volunteers
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg inclusive - Healthy volunteers and COPD patients
* Be able to inhale from the Turbuhaler® inhaler according to given instructions as well as be able to perform spirometry -Healthy volunteers and COPD patients.
* Male COPD patients or female COPD patients of non-childbearing potential (post menopausal or surgically sterilised) aged ≥40 years at Visit 1 - COPD patients
* Female healthy volunteers and female patients ≤60 years must have a negative pregnancy test at screening and on admission to the unit - Healthy volunteers and COPD patients

Exclusion Criteria

* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome - Healthy volunteers and COPD patients
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8683 or excipients:Healthy volunteers and COPD patients
* History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs - Healthy volunteers and COPD patients
* Any clinically significant illness (other than COPD), medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - COPD patients
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - Healthy volunteers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carin Jorup

Role: STUDY_DIRECTOR

AstraZeneca Research and Development SE-431 83 Molndal Sweden

Locations

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London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Eudract 2011-005588-25

Identifier Type: -

Identifier Source: secondary_id

D1883C00002

Identifier Type: -

Identifier Source: org_study_id