AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-10-31

Brief Summary

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This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.

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Detailed Description

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Conditions

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Healthy

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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AZD7268

Group Type EXPERIMENTAL

AZD7268

Intervention Type DRUG

Single Oral

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single Oral

Interventions

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AZD7268

Single Oral

Intervention Type DRUG

Placebo

Single Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive
* Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)

* 18 to ≤ 27 kg/m2

Exclusion Criteria

* Clinically relevant disease or disorder (past or present), 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
* Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor
* Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes