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

A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Male and Non-fertile Female, Young and Elderly Healthy Volunteers, After Oral Multiple Ascending Doses

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902993

Enrollment

Registered

2009-05-15

Start date

2009-04-30

Completion date

2009-09-30

Last updated

2009-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

MAD, NNR, to investigate safety and tolerability in a multiple ascending dose study in Healthy subjects, AZD1446

Brief summary

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.

Interventions

DRUGAZD1446

Solution, oral single and multiple dose

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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,	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.	during the whole study period, ca 43 days

Secondary

Measure	Time frame
Part A: To determine the single and multiple dose PK of AZD1446 in male and non-fertile female Healthy Volunteers.	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.	PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026