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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01069822
First received: February 15, 2010
Last updated: June 30, 2010
Last verified: June 2010
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01069822     History of Changes
Other Study ID Numbers: D6702C00008
Study First Received: February 15, 2010
Last Updated: June 30, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Midazolam
Pharmacokinetics

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

ClinicalTrials.gov processed this record on May 23, 2013