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Completed

NCT Number: NCT00879346

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Alderley Park, Cheshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD8931

Drug

160mg oral single dose (4 x 40mg tablets)

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Study completion
2009
First posted
Apr 10, 2009
Registry last updated
Oct 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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