This Study Will Assess the Safety and Tolerability of AZD8418 After Single Increasing Oral Doses

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-03-31

Brief Summary

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The main purpose of this study is to assess the safety and tolerability of AZD8418 after single increasing oral doses.

Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Part B of the study will assess the effect of food on the safety and pharmacokinetics of AZD8418.

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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

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

AZD8418

Intervention Type DRUG

Single oral dose

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single oral dose

Interventions

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AZD8418

Single oral dose

Intervention Type DRUG

Placebo

single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers
* Healthy female volunteers of non-childbearing potential

Exclusion Criteria

* History of any clinically significant medical, neurologic, or psychiatric disease (including repeated episodes of major depression) or a disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8418

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes