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A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects

NCT ID: NCT01739647

Last Updated: 2013-08-27

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

2012-12-31

Study Completion Date

2013-05-31

Brief Summary

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This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease

Detailed Description

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A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers

Conditions

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Healthy Young Volunteers Healthy Elderly Volunteers

Keywords

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AZD3293 Healthy volunteers Elderly volunteers Phase 1 Single Ascending Dose Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD3293

Up to 11 sequential cohorts of healthy young and healthy elderly subjects are planned, with single ascending doses ranging from 1mg to a maximum of 1000mg

Group Type EXPERIMENTAL

AZD3293

Intervention Type DRUG

Oral solution

Placebo

Placebo given (2 subjects in each cohort)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution

Interventions

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AZD3293

Oral solution

Intervention Type DRUG

Placebo

Oral solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female (of non-childbearing potential) subjects
* Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria

* History or presence of psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
* History of neurological disease, including seizures, recent memory impairment, or clinically significant head injury
* History of use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs
* Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert C Alexander, MD

Role: STUDY_DIRECTOR

AstraZeneca

Ronald Goldwater, MD

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

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Research Site

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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D5010C00001

Identifier Type: -

Identifier Source: org_study_id