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Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers

NCT ID: NCT01348737

Last Updated: 2012-04-06

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

2011-06-30

Study Completion Date

2011-11-30

Brief Summary

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The purpose of the study is to assess the safety, tolerability and blood concentration of AZD3839 following oral administration of single doses in healthy men and women of non-childbearing potential

Detailed Description

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Conditions

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Alzheimer's Disease Safety Tolerability Blood Concentration Healthy Volunteers

Keywords

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Phase 1 healthy volunteers double-blind placebo-controlled AZD3839 pharmacokinetics Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AZD3839

Oral Treatment

Group Type EXPERIMENTAL

AZD3839

Intervention Type DRUG

Single Oral Dose

AZD3839 Placebo

Oral Treatment

Group Type PLACEBO_COMPARATOR

AZD3839 Placebo

Intervention Type DRUG

Single Oral Dose

Interventions

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AZD3839

Single Oral Dose

Intervention Type DRUG

AZD3839 Placebo

Single Oral Dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female volunteers of non-childbearing potential aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weigh between 50 kg and 100 kg (inclusive)
* Creatinine clearance in the normal range (\>80 mL/min estimated according to Cockroft-Gault)
* Healthy volunteers should have a serum potassium concentration of ≥3.8 mmol/L at screening (Visit 1) and on admission to the study centre (Day -1)
* Clinically normal findings on physical examination 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 healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study
* History of psychotic disorder amongst first degree relatives
* Significant orthostatic reaction at enrolment as judged by the Investigator
* Prolonged QTcF greater than 450 msec or shortened QTcF less than 340 msec or family history of long QT syndrome or sudden death
* Healthy volunteer is a vegetarian/lactose intolerant (exclusion criterion only applicable for healthy volunteers participating in Part 2
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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Dr Darren Wilbraham, MBBS DCPSA

Role: PRINCIPAL_INVESTIGATOR

Quintiles Drug Research Unit at Guy's Hospital

Dr Paul Bjornsson

Role: STUDY_DIRECTOR

AstraZeneca

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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2011-001337-16

Identifier Type: -

Identifier Source: secondary_id

D4080C00001

Identifier Type: -

Identifier Source: org_study_id