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

Tracking Information
First Submitted Date ICMJE	September 12, 2008
First Posted Date ICMJE	September 15, 2008
Last Update Posted Date	October 29, 2008
Study Start Date ICMJE	September 2008
Actual Primary Completion Date	October 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 12, 2008)	PK variables [ Time Frame: Several PK samples during the study days ]
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; (submitted: September 12, 2008)	Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs) [ Time Frame: During the whole treatment period ]
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; Intervention Model: Crossover Assignment; Masking: None (Open Label)
Condition ICMJE	Healthy
Intervention ICMJE	Drug: AZD0328; Oral capsule, single dose
Study Arms	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
Actual Enrollment ICMJE; (submitted: September 12, 2008)	14
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	October 2008
Actual 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.
Sex/Gender	Sexes Eligible for Study: 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	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	AstraZeneca
Verification Date	October 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP