NCT01069822

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.)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

3 months

First QC Date

February 15, 2010

Last Update Submit

October 10, 2014

Conditions

Healthy

Keywords

MidazolamPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations

    on Day -1 and Day 6

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

midazolam + AZD6765 IV solution

Drug: AZD6765Drug: midazolam

2

ACTIVE COMPARATOR
Drug: midazolam

Interventions

AZD6765DRUG

IV solution

1
midazolamDRUG
12

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 19-30

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Links

MeSH Terms

Interventions

AZD6765Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Willie Earley, MD

    AstraZeneca

    STUDY DIRECTOR

  • Brendan Smyth, MD, Ph.D

    AstraZeneca

    STUDY DIRECTOR

  • Phil Leese, MD

    Quintiles, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2010

First Posted

February 17, 2010

Study Start

February 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 13, 2014

Record last verified: 2014-10

Locations

US(1)