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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: AZD1446

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: AZD1446 Low; Low dose of AZD1446	Drug: AZD1446; Solution, oral, for 4 weeks
Experimental: AZD1446 High; High dose of AZD1446	Drug: AZD1446; Solution, oral, for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Bo Fransson, MD, PhD, AstraZeneca R&DClinical Pharmacology Unit CPUTunavägen 22aS-221 87 LundSweden; Study Director: Björn Paulsson, MD, PhD, AstraZeneca R&D SödertäljeSE-151 85 SödertäljeSweden

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: October 12, 2009
• First Submitted That Met QC Criteria: October 16, 2009
• First Posted (Estimate): October 19, 2009

Study Record Updates

• Last Update Posted (Estimate): January 22, 2010
• Last Update Submitted That Met QC Criteria: January 21, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: AZD1446; to investigate safety and tolerability in Healthy subjects during 4 weeks of administration
• Other Study ID Numbers: D1950C00009; EudraCT No.2009-013390-18