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A Single and Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Japanese Subjects

NCT ID: NCT01096563

Last Updated: 2010-12-03

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

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This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after administration of single and Multiple Ascending doses in Japanese subjects.

Detailed Description

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Conditions

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Healthy

Keywords

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Phase I Japanese healthy volunteer AZD9164

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

AZD9164

Group Type EXPERIMENTAL

AZD9164

Intervention Type DRUG

Dry powder for inhalation via Turbuhaler, JSMAD. A single dose of AZD9164 on Day 1 and repeated dosing on Day 4 to day 15 (JSMAD).

The starting dose will be 400 μg delivered dose and subsequent doses are planned to be 1000 μg and 2800 μg delivered dose.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dry powder for inhalation via Turbuhaler, JSMAD.

Interventions

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AZD9164

Dry powder for inhalation via Turbuhaler, JSMAD. A single dose of AZD9164 on Day 1 and repeated dosing on Day 4 to day 15 (JSMAD).

The starting dose will be 400 μg delivered dose and subsequent doses are planned to be 1000 μg and 2800 μg delivered dose.

Intervention Type DRUG

Placebo

Dry powder for inhalation via Turbuhaler, JSMAD.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese subjects with suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 18 and 27 kg/m2 and a body weight between 50 and 85 kg
* Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

Exclusion Criteria

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* History or presence of gastrointestinal, 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 investigational product
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Ulrike Lorch, MD MFPM FRCA

Role: PRINCIPAL_INVESTIGATOR

Richmond Pharmacology Limited

Carin Jorup

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Croydon, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Jorup C, Bengtsson T, Strandgarden K, Sjobring U. Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies. BMC Pulm Med. 2014 Mar 27;14:52. doi: 10.1186/1471-2466-14-52.

Reference Type DERIVED
PMID: 24669829 (View on PubMed)

Other Identifiers

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2009-015560-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D1882C00004

Identifier Type: -

Identifier Source: org_study_id