Healthy
Conditions
Keywords
Healthy Volunteers, ADME, Healthy male volunteers
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.
Interventions
DRUGAZD8931
160mg oral single dose (4 x 40mg tablets)
Sponsors
AstraZeneca
Study design
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Countries
United Kingdom
Outcome results
None listed