We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00803855
First Posted: December 8, 2008
Last Update Posted: May 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
December 5, 2008
December 8, 2008
May 15, 2009
December 2008
April 2009   (Final data collection date for primary outcome measure)
Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables [ Time Frame: From first to last visit ]
Same as current
Complete list of historical versions of study NCT00803855 on ClinicalTrials.gov Archive Site
  • Determine the single ascending dose pharmacokinetics of AZD1446 [ Time Frame: 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 ]
Same as current
Not Provided
Not Provided
 
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
Drug: AZD1446
oral, single dose
  • Experimental: AZD1446 Oral or placebo
    Single oral administration of AZD1446 or placebo
    Intervention: Drug: AZD1446
  • Experimental: AZD1446 Oral, with or without food
    Single oral administration of AZD1446 with or without food
    Intervention: Drug: AZD1446
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
April 2009
April 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00803855
D1950C00001
EudraCT No.: 2008-006228-76
No
Not Provided
Not Provided
Didier Meulien, MD, PhD, Medical Science Director, Clinical Neuroscience, Therapeutic area Alzheimers Disease and Cognition, AstraZeneca R&D Södertälje
AstraZeneca
Not Provided
Study Director: Didier Meulien, MD, PhD, MSD AstraZeneca Södertälje
Principal Investigator: Ingemar Bylesjö, MD, PhD AstraZeneca CPU Huddinge
AstraZeneca
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP