A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels
- Registration Number
- NCT01069822
- Lead Sponsor
- AstraZeneca
- 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.)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
- BMI between 19-30
Exclusion Criteria
- Significant result for C-SSRS at screening or baseline
- Single arm preference for IV procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AZD6765 midazolam + AZD6765 IV solution 1 midazolam midazolam + AZD6765 IV solution 2 midazolam -
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations on Day -1 and Day 6
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇺🇸Overland Park, Kansas, United States