A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Elderly Male and Female Volunteers During 4 Weeks of Treatment

AstraZeneca1 site in 1 country97 target enrollmentOctober 2009

ConditionsHealthy

InterventionsAZD1446 Placebo

DrugsAZD1446 Placebo

Overview

Phase: Phase 1
Intervention: AZD1446
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 97
Locations: 1
Primary Endpoint: To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure).
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

December 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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.

Arms & Interventions

AZD1446 High

High dose of AZD1446

Intervention: AZD1446

AZD1446 Low

Low dose of AZD1446

Intervention: AZD1446

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure).

Time Frame: During the whole study period, Study days 1-68 (30 days of enrolment , study day 1-28 and follow up visit study days 35-38).

Secondary Outcomes

To determine the PK of AZD1446 dosed for 4 weeks in healthy elderly male and female volunteers. PK parameters include renal clearance, AUC (0-24)ss and T1/2 eff.(PK sampling taken at defined timepoints during the treatment period (study days 1-28))