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

AstraZeneca97 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

AZD1446DRUG

Solution, oral, for 4 weeks

PlaceboDRUG

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research

Lund, Sweden

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.

Time frame: PK sampling taken at defined timepoints during the treatment period (study days 1-28)

Data from ClinicalTrials.gov

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