A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels
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...
Brief Summary
Official Title: “A Phase I Open-label, Fixed Sequence Study to Determine the Effect of Multiple Intravenous Doses of AZD6765 on the Pharmacokinetics of Oral Midazolam (CYP3A4 Substrate) in Healthy Subjects”
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.)
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
- Study Primary Completion Date: May 2010
Intervention(s) in this Clinical Trial
- Drug: AZD6765
- IV solution
- Drug: midazolam
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- midazolam + AZD6765 IV solution
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations
- Time Frame: on Day -1 and Day 6
Safety Issue?: No
- Time Frame: on Day -1 and Day 6
Secondary Measures
- 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.
Safety Issue?: Yes
- 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
Safety Issue?: No
- Time Frame: at admission Day -2
- Exploratory - renal biomarkers in urine
- Time Frame: At admission Day -2 until follow up visit
Safety Issue?: No
- Time Frame: At admission Day -2 until follow up visit
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- BMI between 19-30
Exclusion Criteria:
- Significant result for C-SSRS at screening or baseline
- Single arm preference for IV procedures
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Willie Earley, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01069822
Study ID Number: D6702C00008
ClinicalTrials.gov Identifier: NCT01069822
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01069822
