To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00752830

First received: September 12, 2008

Last updated: October 28, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2008

Last Updated Date

October 28, 2008

Start Date ^ICMJE

September 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00752830 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: AZD0328

Oral capsule, single dose

Study Arm (s)

Experimental: 1
AZD0328 administration during fasting condition

Intervention: Drug: AZD0328
Experimental: 2
AZD0328 administration after food intake

Intervention: Drug: AZD0328

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

20 Years to 45 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Sweden

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00752830

Other Study ID Numbers ^ICMJE

D0190C00009, EUdract NO 2008-003691-22

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Didier Meulien, MD, Medical Science Director, Emerging AD & Cognition, AstraZeneca R&D, Södertälje, Sweden

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

AstraZeneca

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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