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
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 April 16, 2014