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

This study has been completed.

First Received on June 9, 2008. Last Updated on September 23, 2011 History of Changes

Sponsor:	Stiefel, a GSK Company
Collaborator:	GlaxoSmithKline
Information provided by (Responsible Party):	GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:	NCT00695071

Purpose

The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.

Condition	Intervention	Phase
Healthy	Drug: Itraconazole	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Assessment of the Steady State Pharmacokinetics of Itraconazole and Hydroxy-Itraconazole in Healthy Subjects After Administration of a New Itraconazole 200 mg Film Coated Tablet Once Daily for Fourteen Days in Fed Condition

Resource links provided by NLM:

Drug Information available for: Itraconazole

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Steady State Plasma levels of Itraconazole [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	June 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	Drug: Itraconazole Oral

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695071

Locations

United States, New Jersey
Advanced Biomedical Research
Hackensack, New Jersey, United States, 07601

Sponsors and Collaborators

Stiefel, a GSK Company

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:	NCT00695071 History of Changes
Other Study ID Numbers:	BT0300-108-USA
Study First Received:	June 9, 2008
Last Updated:	September 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Healthy Volunteers

Additional relevant MeSH terms:

Hydroxyitraconazole
Itraconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012