A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy Volunteers

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

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-12-31

Brief Summary

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This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two doses of AZD1446 or placebo in subjects when given for 4 weeks.

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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

DOUBLE

Participants Investigators

Study Groups

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AZD1446 Low

Low dose of AZD1446

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

Solution, oral, for 4 weeks

AZD1446 High

High dose of AZD1446

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

Solution, oral, for 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD1446

Solution, oral, for 4 weeks

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or non-fertile female, elderly Subjects, aged ≥65 to ≤85
* Body mass index (BMI) between 18 and 30 kg/m2
* Clinically normal findings on physical examination

Exclusion Criteria

* History of any clinically significant disease or disorder
* History of severe allergy/hypersensitivity reactions including severe food allergy as judged by the investigator.

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes