AZD1981 Midazolam CYP4503A Induction Study | NCT00859352

Studies
AZD1981 Midazolam CYP4503A Induction Study

NCT00859352

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Apr 10, 2009Estimated

Enrollment

28Estimated

Phase

Phase 1

Conditions

Healthy Male Volunteer

Interventions

AZD1981
Midazolam

Countries

Sweden

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

ID	Type	Description	Link
EudraCT No. 2008-008224-32

Status Module

Record Verification Date

Apr 2009

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

Mar 2009

Primary Completion Date

Not provided

Completion Date

Apr 2009Actual

First Submitted Date

Mar 10, 2009

First Submission Date that Met QC Criteria

Mar 10, 2009

First Posted Date

Mar 11, 2009Estimated

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

Apr 9, 2009

Last Update Posted Date

Apr 10, 2009Estimated

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 primary objective of the study is to investigate if the exposure of midazolam is clinically significantly changed by 14 days of exposure to AZD1981 through possible enzyme induction of CYP3A.

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

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	AZD1981 100mg and Midazolam	Drug: AZD1981 Drug: Midazolam
2	Experimental	AZD1981 500mg and Midazolam	Drug: Midazolam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD1981	Drug	oral tablets during 14 consecutive days.	1
Midazolam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PK samples for both AZD1981 and Midazolam.		Intense PK-sampling during 3 pre-defined study days for PK profiling and some sampling throughout the whole study period for confirmatory purposes

Secondary Outcomes

Measure	Description	Time Frame
Sampling of 4β-hydroxycholesterol		Taken at baseline and after steady state of AZD1981
Safety variables (adverse events and laboratory safety lab)		Adverse events taken during study and safety lab at a few time points

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1 (pre-entry)

Exclusion Criteria:

Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study

Accepts Healthy Volunteers

Yes

Sex

Male

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
Eva Pettersson	AstraZeneca R&D, Lund, Sweden	Study Director
Aslak Rautio	Quintiles Hermelinen AB, Luleå, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Uppsala			Sweden

Intervention Browse Module

MeSH Terms

ID	Term
C569518	AZD1981
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