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AZD Single Ascending Dose Study In Healthy Japanese Subjects

NCT ID: NCT01028040

Last Updated: 2010-12-10

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-08-31

Brief Summary

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This is a single centre, open label, non-randomised study to access the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to Japanese subjects.

Detailed Description

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Conditions

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Healthy

Keywords

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Phase I AZD3043 Japanese healthy volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AZD3043

Group Type EXPERIMENTAL

AZD3043

Intervention Type DRUG

Intravenous, single dose

AZD3043

Intervention Type DRUG

Infusion, single dose

Interventions

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AZD3043

Intravenous, single dose

Intervention Type DRUG

AZD3043

Infusion, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese male and females of non-childbearing potential aged ≥20 to ≤ 45 with suitable veins for cannulation or repeated venepuncture.
* Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
* Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the Investigator.

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/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator
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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Dr. Ulrike Lorch, MFPM FRCA

Role: PRINCIPAL_INVESTIGATOR

Richmond Pharmacology Limited

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D0510C00004

Identifier Type: -

Identifier Source: org_study_id