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

May 14, 2009 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Huddinge, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD1446 Oral or placebo
Single oral administration of AZD1446 or placebo
Drug: AZD1446
oral, single dose
Experimental: AZD1446 Oral, with or without food
Single oral administration of AZD1446 with or without food
Drug: AZD1446
oral, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
Time Frame: From first to last visit
From first to last visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the single ascending dose pharmacokinetics of AZD1446
Time Frame: PK sampling taken at defined timepoints during residential period
PK sampling taken at defined timepoints during residential period
Determine the single dose of AZD1446 on food interaction
Time Frame: From first to last visit
From first to last visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Didier Meulien, MD, PhD, MSD, AstraZeneca Södertälje
  • Principal Investigator: Ingemar Bylesjö, MD, PhD, AstraZeneca CPU Huddinge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 5, 2008

First Posted (Estimate)

December 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 15, 2009

Last Update Submitted That Met QC Criteria

May 14, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1950C00001
  • EudraCT No.: 2008-006228-76

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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