Study to Assess Blood Levels of Itraconazole During a Two... | NCT00695071

Studies
Study to Assess Blood Levels of Itraconazole During a Two-Week Period

NCT00695071

Sponsor

Stiefel, a GSK Company

Status

Completed

Last Update Posted

Sep 26, 2011Estimated

Enrollment

16Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Itraconazole

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

Sep 2011

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

Jun 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Jun 9, 2008

First Submission Date that Met QC Criteria

Jun 10, 2008

First Posted Date

Jun 11, 2008Estimated

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

Sep 23, 2011

Last Update Posted Date

Sep 26, 2011Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

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

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

16Actual

Label	Type	Description	Intervention Names
A	Active Comparator		Drug: Itraconazole

Name	Type	Description	Arm Group Labels	Other Names
Itraconazole	Drug	Oral	A

Measure	Description	Time Frame
Steady State Plasma levels of Itraconazole		2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI between 18.0 and 28.0 kg/m2
Good physical and mental health status, determined on the basis of the medical history and a general clinical examination.
Vital signs (blood pressure and heart rate) in supine position within the normal range
Electrocardiogram (12 lead) considered as normal
Non-smoker.
Able to swallow pills
If subject is a woman of childbearing potential (WOCBP), must agree to use adequate birth control as defined by the protocol

Exclusion Criteria:

Any disease or physical condition which, in the opinion of the investigator, could impact the pharmacokinetics of the drug
History or presence of drug abuse or consumption of alcohol
History of sensitivity or allergy to azoles or related drugs
Any requirement to be on other drug treatment (except acetaminophen and for WOCBP, hormonal contraceptives)
Unsuitable veins for repeated venipuncture.
Clinically significant abnormal ECG
Nursing mothers and pregnant women, or women of childbearing potential not using adequate contraceptives.

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
GSK Clinical Trials, MD	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Biomedical Research		Hackensack	New Jersey	07601	United States

Intervention Browse Module

MeSH Terms

ID	Term
D017964	Itraconazole

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided