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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00803855
First received: December 5, 2008
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the single ascending dose pharmacokinetics of AZD1446 [ Time Frame: PK sampling taken at defined timepoints during residential period ] [ Designated as safety issue: No ]
  • Determine the single dose of AZD1446 on food interaction [ Time Frame: From first to last visit ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00803855

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

No publications provided

Responsible Party: Didier Meulien, MD, PhD, Medical Science Director, Clinical Neuroscience, Therapeutic area Alzheimers Disease and Cognition, AstraZeneca R&D Södertälje
ClinicalTrials.gov 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
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
single dose
pharmacokinetics
safety
healthy volunteers
food interaction
AZD1446

ClinicalTrials.gov processed this record on July 20, 2014