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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: February 15, 2010
Last updated: October 10, 2014
Last verified: October 2014

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
Drug: AZD6765
Drug: midazolam
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: Yes ]
  • Optional Genetic sampling [ Time Frame: at admission Day -2 ] [ Designated as safety issue: No ]
  • Exploratory - renal biomarkers in urine [ Time Frame: At admission Day -2 until follow up visit ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01069822

United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Study Director: Willie Earley, MD AstraZeneca
Study Director: Brendan Smyth, MD, Ph.D AstraZeneca
Principal Investigator: Phil Leese, MD Quintiles
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca Identifier: NCT01069822     History of Changes
Other Study ID Numbers: D6702C00008
Study First Received: February 15, 2010
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on November 25, 2014