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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Itraconazole

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A	Drug: Itraconazole; Oral

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stiefel, a GSK Company
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: June 9, 2008
• First Submitted That Met QC Criteria: June 10, 2008
• First Posted (Estimate): June 11, 2008

Study Record Updates

• Last Update Posted (Estimate): September 26, 2011
• Last Update Submitted That Met QC Criteria: September 23, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: BT0300-108-USA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No