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

NCT ID: NCT01069822

Last Updated: 2014-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-05-31

Brief Summary

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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.)

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

midazolam + AZD6765 IV solution

Group Type EXPERIMENTAL

AZD6765

Intervention Type DRUG

IV solution

midazolam

Intervention Type DRUG

2

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

Interventions

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AZD6765

IV solution

Intervention Type DRUG

midazolam

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI between 19-30

Exclusion Criteria

* Significant result for C-SSRS at screening or baseline
* Single arm preference for IV procedures
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Willie Earley, MD

Role: STUDY_DIRECTOR

AstraZeneca

Brendan Smyth, MD, Ph.D

Role: STUDY_DIRECTOR

AstraZeneca

Phil Leese, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=572&filename=D6702C00008_Clinical_Study_Report_Synopsis.pdf

D6702C00008 Clinical Study Report Synopsis

Other Identifiers

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D6702C00008

Identifier Type: -

Identifier Source: org_study_id

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