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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00879346
First received: April 7, 2009
Last updated: October 22, 2009
Last verified: October 2009
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
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: 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

No publications provided

Responsible Party: Dr Mary Staurt, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00879346     History of Changes
Other Study ID Numbers: D0102C00011
Study First Received: April 7, 2009
Last Updated: October 22, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Healthy Volunteers
ADME
Healthy male volunteers

ClinicalTrials.gov processed this record on October 23, 2014