CClinicalTrials.gg
Sign In
CompletedNCT00902993Updated Oct 1, 2009

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

A Phase 1 interventional study of AZD1446 and Placebo in Healthy, sponsored by AstraZeneca. Completed at 2 sites in Sweden. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-01.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • MAD
  • NNR
  • to investigate safety and tolerability in a multiple ascending dose study in Healthy subjects
  • AZD1446
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • History of any clinically significant disease or disorder
  • History of severe allergy/hypersensitivity reactions
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    1

    Part A single and multiple dose and part B fractionated dose

    Drug: AZD1446

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugAZD1446

    Solution, oral single and multiple dose

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

07

Study locations

2 sites
  • Research Site
    Goteborg, Sweden
  • Research Site
    Stockholm, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00902993
Lead sponsor
AstraZeneca
First posted
May 15, 2009
Start date
Apr 2009
Completion
Sep 2009
Last update
Oct 1, 2009

Study contacts

Björn Paulsson, MD, PhD
study director · AstraZeneca
Marianne Hartford, MD PhD
principal investigator · AstraZeneca Clinical Pharmacology Unit (CPU) Sahlgrenska University Hospital GöteborgSE-413 45 GöteborgSweden
Ingemar Bylesjo, MD PhD
principal investigator · AstraZeneca Clinical Pharmacology Unit (CPU) C2:84Karolinska University Hospital HuddingeSE-141 86 StockholmSweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

AstraZeneca

Start the discussion