Healthy
Conditions
Keywords
Phase I
Brief summary
The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on the blood levels of midazolam and caffeine in healthy volunteers
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects aged 18 to 45 years (inclusive) on Day 1.
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 AZD6280 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 throughout the 19-day inpatient period of the study. |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of repeated doses of AZD6280 in combination with midazolam and caffeine. | Observations taken post dosing. |
| Evaluation of the pharmacodynamic effects of AZD6280 | Test batteries will be performed before and following study drug administration. |
| To evaluate the pharmacokinetics of AZD6280 | Blood samples will be taken throughout the 19-day inpatient period of the study. |
Countries
United Kingdom
Outcome results
None listed