Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers - Full Text View

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

This study is currently recruiting participants.

Verified by AstraZeneca, December 2008

First Received: December 5, 2008 No Changes Posted

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00803855

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 I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study
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 ]

Estimated Enrollment:	82
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AZD1446 Oral or placebo: Experimental Single oral administration of AZD1446 or placebo	Drug: AZD1446 oral, single dose
AZD1446 Oral, with or without food: Experimental Single oral administration of AZD1446 with or without food	Drug: AZD1446 oral, single dose

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803855

Contacts

Contact: Lena Bolin, SDD

+46 8 553 26000

Locations

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:	AstraZeneca R&D Södertälje ( Didier Meulien, MD, PhD, Medical Science Director, Clinical Neuroscience, Therapeutic area Alzheimers Disease and Cognition )
Study ID Numbers:	D1950C00001, EudraCT No.: 2008-006228-76
Study First Received:	December 5, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00803855 History of Changes
Health Authority:	Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

single dose
pharmacokinetics
safety

healthy volunteers
food interaction
AZD1446

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009