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OpenTrials
Completed

NCT Number: NCT00803855

Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research site

Huddinge, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • physical healthy volunteers
  • weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2

Exclusion criteria

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

Treatment and study plan

AZD1446

Drug

oral, single dose

Primary outcomes

  1. Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables

    Time frame: From first to last visit

Secondary outcomes

  1. Determine the single ascending dose pharmacokinetics of AZD1446

    Time frame: PK sampling taken at defined timepoints during residential period

  2. Determine the single dose of AZD1446 on food interaction

    Time frame: From first to last visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel in Healthy Male and Non-Fertile Female Volunteers

Acronym: SAD

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 8, 2008
Registry last updated
May 15, 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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