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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01069822
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Duration (Months): 2.9
• Patients Per Site Per Month: 15.7

Study Details

Study Description

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.)

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD6765; Drug: midazolam	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• 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
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 midazolam + AZD6765 IV solution	Drug: AZD6765; IV solution; Drug: midazolam
Active Comparator: 2	Drug: midazolam

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. 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.]

2. Optional Genetic sampling [at admission Day -2]

3. Exploratory - renal biomarkers in urine [At admission Day -2 until follow up visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Overland Park	Kansas	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Willie Earley, MD, AstraZeneca
• Study Director: Brendan Smyth, MD, Ph.D, AstraZeneca
• Principal Investigator: Phil Leese, MD, Quintiles, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• D6702C00008 Clinical Study Report Synopsis

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01069822
• Other Study ID Numbers: D6702C00008
• First Posted: Feb 17, 2010
• Last Update Posted: Oct 13, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by AstraZeneca: Midazolam; Pharmacokinetics
• Additional relevant MeSH terms: Midazolam

Study Results

No Results Posted as of Oct 13, 2014