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OpenTrials
Completed

NCT Number: NCT00902993

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

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1446

Drug

Solution, oral single and multiple dose

Placebo

Drug

Placebo

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Study completion
2009
First posted
May 15, 2009
Registry last updated
Oct 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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