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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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
Experimental: 1
AZD0328 administration during fasting condition
Drug: AZD0328
Oral capsule, single dose
Experimental: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by AstraZeneca:
AZD0328
Food Effect

ClinicalTrials.gov processed this record on July 20, 2014