Healthy Volunteer
Conditions
Keywords
Phase I
Brief summary
To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine \[3-desmethyl\] metabolite).
Interventions
DRUGAZD7325
Oral, day 1-12
DRUGMidazolam
single dose, twice during treatment
DRUGCaffeine
single dose, twice during treatment
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Exclusion criteria
* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor. * Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite). | Blood samples will be taken during the study. |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of repeated doses of AZD7325 in combination with midazolam and caffeine. | Blood samples will be taken during the study. |
| Evaluation of the pharmacodynamic effects of AZD7325 | Test batteries will be performed at specified times both before and following study drug administration. |
| To evaluate the pharmacokinetics of AZD7325 | Blood samples will be taken on Days 1, 11 and 12. |
Outcome results
None listed