A Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets
- Registration Number
- NCT00879346
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 AZD8931 160mg oral dose of AZD8931
- Primary Outcome Measures
Name Time Method To investigate the effect of food on the pharmacokinetics of AZD8931 160mg oral dose Multiple blood PK samples taken between predose to up to 5 days post last dose
- Secondary Outcome Measures
Name Time Method To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG Maximus of 7 weeks (From time of consent to last visit including any follow-up)
Trial Locations
- Locations (1)
Research Site
🇬🇧Alderley Park, Cheshire, United Kingdom