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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879346
First Posted: April 10, 2009
Last Update Posted: October 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Healthy Drug: AZD8931 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets in Healthy Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 24
Study Start Date: March 2009
Study Completion Date: July 2009
Arms Assigned Interventions
Experimental: 1
160mg oral dose of AZD8931
Drug: AZD8931
160mg oral single dose (4 x 40mg tablets)

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879346


Locations
United Kingdom
Research Site
Alderley Park, Cheshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Emeline Ramos, MD AstraZeneca, Clinical Pharamcology Unit, Alderley Park
Study Director: Mary Stuart, MD AstraZeneca
  More Information

Responsible Party: Dr Mary Staurt, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00879346     History of Changes
Other Study ID Numbers: D0102C00011
First Submitted: April 7, 2009
First Posted: April 10, 2009
Last Update Posted: October 23, 2009
Last Verified: October 2009

Keywords provided by AstraZeneca:
Healthy Volunteers
ADME
Healthy male volunteers