Healthy
Conditions
Keywords
Midazolam, Pharmacokinetics
Brief summary
The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug being developed for the treatment of patients with severe major depressive disorder) has on the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your body and acts in the body.)
Interventions
DRUGAZD6765
IV solution
DRUGmidazolam
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI between 19-30
Exclusion criteria
* Significant result for C-SSRS at screening or baseline * Single arm preference for IV procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations | on Day -1 and Day 6 |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables (adverse events, vital signs, physical and neurological examinations, clinical laboratory assessments, 12-lead ECG, C-SSRS, CADSS, and VAS scales) | will be collected from the time of informed consent (Visit 1) until completion of the follow-up visit. |
| Optional Genetic sampling | at admission Day -2 |
| Exploratory - renal biomarkers in urine | At admission Day -2 until follow up visit |
Countries
United States
Outcome results
None listed