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

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. Identifier: NCT00803855
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : May 15, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD1446 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : December 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00803855

Research site
Huddinge, Sweden
Sponsors and Collaborators
Study Director: Didier Meulien, MD, PhD, MSD AstraZeneca Södertälje
Principal Investigator: Ingemar Bylesjö, MD, PhD AstraZeneca CPU Huddinge

Responsible Party: Didier Meulien, MD, PhD, Medical Science Director, Clinical Neuroscience, Therapeutic area Alzheimers Disease and Cognition, AstraZeneca R&D Södertälje Identifier: NCT00803855     History of Changes
Other Study ID Numbers: D1950C00001
EudraCT No.: 2008-006228-76
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009

Keywords provided by AstraZeneca:
single dose
healthy volunteers
food interaction