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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

160mg oral dose of AZD8931

Group Type EXPERIMENTAL

AZD8931

Intervention Type DRUG

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

Interventions

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AZD8931

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes