Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446

AstraZeneca80 enrolled

Overview

This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6 multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

AZD1446DRUG

Solution, oral single and multiple dose

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or non-fertile female, young or elderly Subjects, aged ≥18 to ≤50 or ≥65 to ≤80 * Body mass index (BMI) between 19 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

Locations (2)

Research Site

Gothenburg, Sweden

Research Site

Stockholm, Sweden

Outcomes

Primary Outcomes

Part A: to assess the safety and tolerability of AZD1446 following multiple ascending doses of an orally administered solution of AZD1446 in male and non-fertile female, young and elderly Healthy Volunteers,

Time frame: during the whole study period, ca 50 days

Part B: to assess the safety and tolerability of AZD1446 following administration of an oral solution of AZD1446 as fractionated doses during one day in male and non-fertile female, young and elderly Healthy Volunteers.

Time frame: during the whole study period, ca 43 days

Secondary Outcomes

Part A: To determine the single and multiple dose PK of AZD1446 in male and non-fertile female Healthy Volunteers.

Time frame: PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B

Part B: To mimic an extended release dosing regimen and determine the fractionated dosing PK of AZD1446 in male and non-fertile Healthy Volunteers.

Time frame: PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B

Data from ClinicalTrials.gov

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