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AZD1305 Single and Multiple Ascending Dose Study in Healthy Japanese and Caucasian Subjects

NCT ID: NCT00935025

Last Updated: 2010-12-07

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-11-30

Brief Summary

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This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if needed) dose levels will be given to Japanese subjects and one of the doses will also be given to Caucasian subjects.

Detailed Description

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Conditions

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Healthy

Keywords

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Phase I Japanese healthy volunteer AZD1305 Japanese and Caucasian

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1, AZD1305

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

single and multiple oral doses, extended-release capsule

2, Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single and multiple oral doses, capsule

Interventions

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AZD1305

single and multiple oral doses, extended-release capsule

Intervention Type DRUG

Placebo

single and multiple oral doses, capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese and Caucasian male subjects 20 to 45 years of age inclusive
* Body weight between 50 and 85 kg, inclusive, with a Body Mass Index (BMI) ≥19 to ≤ 27 kg/m2

Exclusion Criteria

* Clinically significant illness, surgical procedure or trauma, within two weeks preceding the pre-entry visit until first administration of IP, as judged by the investigator
* History of clinically significant gastrointestinal, mental, cardiac, renal or hepatic disorder, or other significant disease as judged by the investigator
* Habitual smoker (daily use) of tobacco or daily use of nicotine-containing products
Minimum Eligible Age

20 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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AstraZeneca

Principal Investigators

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Mark Yen, M.D.

Role: PRINCIPAL_INVESTIGATOR

California Clinical Trials

Locations

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Research Site

Glendale, California, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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D3190C00015

Identifier Type: -

Identifier Source: org_study_id