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

October 28, 2008 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK variables
Time Frame: Several PK samples during the study days
Several PK samples during the study days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs)
Time Frame: During the whole treatment period
During the whole treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 12, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (Estimate)

September 15, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2008

Last Update Submitted That Met QC Criteria

October 28, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D0190C00009
  • EUdract NO 2008-003691-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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