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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AZD1446

Study type: Interventional

Funder types: Industry

Identifiers

NCT00997308

EudraCT No.2009-013390-18

D1950C00009

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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97 participants in 3 patient groups, including a placebo group

AZD1446 Low

Experimental group

Description:

Low dose of AZD1446

Treatment:

Drug: AZD1446

AZD1446 High

Experimental group

Description:

High dose of AZD1446

Treatment:

Drug: AZD1446

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo