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To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Inhaled AZD8683

NCT ID: NCT01419600

Last Updated: 2012-07-03

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing single doses of AZD8683 administered via inhalation

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 inhaled AZD8683 after Single Ascending Doses administered via Turbuhaler in Healthy Subjects

Conditions

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Healthy

Keywords

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Phase 1 healthy volunteers safety tolerability pharmacokinetics single ascending dose study

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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Group 1 - 4, single ascending dose AZD 8683

Subjects will participate in 1 of 4 groups. In each group, 6 subjects will receive AZD8683 and 2 subjects will receive placebo.

Group Type EXPERIMENTAL

AZD8683

Intervention Type DRUG

Single Dose Inhaled IMP via Turbuhaler

Group 1-4 single ascending dose Placebo

Subjects will participate in 1 of 4 groups. In each group, 6 subjects will receive AZD8683 and 2 subjects will receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo to match

Intervention Type DRUG

Single dose Inhaled Placebo via Turbuhaler

Interventions

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AZD8683

Single Dose Inhaled IMP via Turbuhaler

Intervention Type DRUG

Placebo to match

Single dose Inhaled Placebo via Turbuhaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures Healthy male subjects aged 18
* 45 years with suitable veins for cannulation or repeated venepuncture
* Male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product
* Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive

Exclusion Criteria

* 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
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
* Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:

* Systolic blood pressure \>140 mm Hg
* Diastolic blood pressure \>90 mm Hg
* Heart rate \<40 or \>85 beats per minute Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG. This includes subjects with any of the following:
* PR(PQ) interval prolongation \>200 ms or dropped beats (single non conducted P-waves) based on screening or Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

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

Darren Wilbraham

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Research Site

London, UK, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2011-002412-87

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D1883C00006

Identifier Type: -

Identifier Source: org_study_id