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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: December 5, 2008
Last updated: May 14, 2009
Last verified: May 2009
The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

Condition Intervention Phase
Healthy Drug: AZD1446 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 110
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: December 5, 2008
Last Updated: May 14, 2009

Keywords provided by AstraZeneca:
single dose
healthy volunteers
food interaction
AZD1446 processed this record on September 19, 2017