A Phase 1 interventional study of AZD6765 and midazolam in Healthy, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-13.
Sponsored by AstraZeneca · Phase 1 and Interventional
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.)
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
midazolam + AZD6765 IV solution
Drug: AZD6765 · Drug: midazolam
Drug: midazolam
IV solution
Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations
Time frame: on Day -1 and Day 6
Safety variables (adverse events, vital signs, physical and neurological examinations, clinical laboratory assessments, 12-lead ECG, C-SSRS, CADSS, and VAS scales)
Time frame: will be collected from the time of informed consent (Visit 1) until completion of the follow-up visit.
Optional Genetic sampling
Time frame: at admission Day -2
Exploratory - renal biomarkers in urine
Time frame: At admission Day -2 until follow up visit
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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AstraZeneca