To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328 - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00752830

Purpose

The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328 in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule) during two treatment periods, after food intake or during fasting condition.

Condition	Intervention	Phase
Healthy	Drug: AZD0328	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Phase I, Open, Randomized, Single-Dose, Two-Treatment (Fed Versus Fasting), Two-Period Cross-Over Single-Centre Study to Evaluate the Effect of Food on the Pharmacokinetics of AZD0328 Following Oral Administration (Capsule) in Healthy Male Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

PK variables [ Time Frame: Several PK samples during the study days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]

Enrollment:	14
Study Start Date:	September 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD0328 administration during fasting condition	Drug: AZD0328 Oral capsule, single dose
2: Experimental AZD0328 administration after food intake	Drug: AZD0328 Oral capsule, single dose

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male Caucasian subjects.
Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.
Signed informed consent form

Exclusion Criteria:

History of clinically significant cardio or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder (including dyspepsia or GERD) or any other major disorder that may interfere with the study.
Intake of another investigational drug or participation in another study which may interfere with the objectives of the study, within 12 weeks before the administration of the investigational product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752830

Locations

Sweden
Research Site
Lund, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Didier Meulien, MD	AstraZeneca R&D Södertälje, Sweden
Principal Investigator:	Gabriella Samuelsson Palmgren, MD	AstraZeneca Clinical Pharmacology Unit, AstraZeneca R&D Lund,Sweden

More Information

No publications provided

Responsible Party:	AstraZeneca R&D, Södertälje, Sweden ( Didier Meulien, MD, Medical Science Director, Emerging AD & Cognition )
Study ID Numbers:	D0190C00009, EUdract NO 2008-003691-22
Study First Received:	September 12, 2008
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00752830 History of Changes
Health Authority:	Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

AZD0328
Food Effect

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009