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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069822
First Posted: February 17, 2010
Last Update Posted: October 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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 Intervention Phase
Healthy Drug: AZD6765 Drug: midazolam Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations [ Time Frame: on Day -1 and Day 6 ]

Secondary Outcome 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. ]
  • Optional Genetic sampling [ Time Frame: at admission Day -2 ]
  • Exploratory - renal biomarkers in urine [ Time Frame: At admission Day -2 until follow up visit ]

Enrollment: 46
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
midazolam + AZD6765 IV solution
Drug: AZD6765
IV solution
Drug: midazolam
Active Comparator: 2 Drug: midazolam

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069822


Locations
United States, Kansas
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.
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01069822     History of Changes
Other Study ID Numbers: D6702C00008
First Submitted: February 15, 2010
First Posted: February 17, 2010
Last Update Posted: October 13, 2014
Last Verified: October 2014

Keywords provided by AstraZeneca:
Midazolam
Pharmacokinetics

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action