A Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets

October 22, 2009 updated by: AstraZeneca

A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets in Healthy Subjects

Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

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

  • United Kingdom
    • Cheshire
      • Alderley Park, Cheshire, United Kingdom
        • 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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Provision of written informed consent
  • Body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

  • Use of any prescribed or non-prescribed medication (including analgesics, herbal remedies, vitamins and minerals) during the two weeks prior to the first administration of investigational product
  • Administration of another investigational medicinal product in the 3 months before the start of dosing in this study
  • Definite or suspected clinically relevant personal history of adverse drug reactions, or drug hypersensitivity

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

  • Primary Purpose: Basic Science
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
160mg oral dose of AZD8931
Drug: AZD8931
160mg oral single dose (4 x 40mg tablets)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate the effect of food on the pharmacokinetics of AZD8931 160mg oral dose
Time Frame: Multiple blood PK samples taken between predose to up to 5 days post last dose
Multiple blood PK samples taken between predose to up to 5 days post last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG
Time Frame: Maximus of 7 weeks (From time of consent to last visit including any follow-up)
Maximus of 7 weeks (From time of consent to last visit including any follow-up)

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Emeline Ramos, MD, AstraZeneca, Clinical Pharamcology Unit, Alderley Park
  • Study Director: Mary Stuart, MD, AstraZeneca

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

March 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria

April 9, 2009

First Posted (Estimate)

April 10, 2009

Study Record Updates

Last Update Posted (Estimate)

October 23, 2009

Last Update Submitted That Met QC Criteria

October 22, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D0102C00011

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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