A Study in Healthy Volunteers to Assess Effect of AZD6765... | NCT01069822

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

NCT01069822

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Oct 13, 2014Estimated

Enrollment

46Actual

Phase

Phase 1

Conditions

Healthy

Interventions

AZD6765
midazolam

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Feb 15, 2010

First Submission Date that Met QC Criteria

Feb 16, 2010

First Posted Date

Feb 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2014

Last Update Posted Date

Oct 13, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	midazolam + AZD6765 IV solution	Drug: AZD6765 Drug: midazolam
2	Active Comparator		Drug: midazolam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD6765	Drug	IV solution	1
midazolam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations		on Day -1 and Day 6

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI between 19-30

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Willie Earley, MD	AstraZeneca	Study Director
Brendan Smyth, MD, Ph.D	AstraZeneca	Study Director
Phil Leese, MD	Quintiles, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Overland Park	Kansas		United States

Label	URL
D6702C00008 Clinical Study Report Synopsis	View source

Intervention Browse Module

MeSH Terms

ID	Term
C585977	AZD6765
D008874	Midazolam

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided