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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

September 12, 2008
October 28, 2008
September 2008
October 2008   (final data collection date for primary outcome measure)
PK variables [ Time Frame: Several PK samples during the study days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00752830 on ClinicalTrials.gov Archive Site
Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
Drug: AZD0328
Oral capsule, single dose
  • Experimental: 1
    AZD0328 administration during fasting condition
    Intervention: Drug: AZD0328
  • Experimental: 2
    AZD0328 administration after food intake
    Intervention: Drug: AZD0328
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00752830
D0190C00009, EUdract NO 2008-003691-22
No
Didier Meulien, MD, Medical Science Director, Emerging AD & Cognition, AstraZeneca R&D, Södertälje, Sweden
AstraZeneca
Not Provided
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
AstraZeneca
October 2008

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