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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014