A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels

NCT01069822 — Phase 1, Completed, 46 participants, AstraZeneca

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01069822
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, single group, masking: none
Enrollment	46 (Actual)
Sponsor	AstraZeneca (Industry)
Conditions	Healthy
Interventions	AZD6765, midazolam (Drug)
Dates	start 2010-02-01, primary completion 2010-05-01, completion 2010-05-01, first posted 2010-02-17, last updated 2014-10-13
Locations	1 site in United States

-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.)

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: AZD6765; Drug: midazolam	midazolam + AZD6765 IV solution
2	Active comparator	Drug: midazolam

AZD6765 (Drug): IV solution
midazolam (Drug)

+Outcome measures

Primary outcomes

Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations [on Day -1 and Day 6]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* BMI between 19-30

Exclusion Criteria:

* Significant result for C-SSRS at screening or baseline
* Single arm preference for IV procedures

+Locations (1)

Facility	City	Country	Status
Research Site	Overland Park, Kansas	United States

+Investigators

Willie Earley, MD, Study director, AstraZeneca
Brendan Smyth, MD, Ph.D, Study director, AstraZeneca
Phil Leese, MD, Principal investigator, Quintiles, Inc.