Healthy Volunteer
Conditions
Keywords
Phase I, pharmacodynamic study
Brief summary
The purpose of the study is to determine the effects of the compound AZD7325 as compared to lorazepam on sleepiness, concentration and brain activity.
Interventions
DRUGAZD7325
AZD7325 10 mg oral 2 capsules
DRUGLorazepam
Lorazepam 1 mg oral 2 tablets
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male aged 18 to 55 years on screening
Exclusion criteria
* Clinically significant illness within 2 weeks before the study start * Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit * Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2 * Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests. | Test batteries will be performed at specified times both before and following study drug administration. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation and characterization of the pharmacokinetics of AZD6280. | Blood samples will be taken during the study. |
Countries
Netherlands
Outcome results
None listed