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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00695071
First received: June 9, 2008
Last updated: September 23, 2011
Last verified: September 2011
History of Changes
  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 1

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:

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:
Itraconazole
Hydroxyitraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013