Determine the Effects of Gene Differences and Voriconazole on Enzyme CYP2B6 Activity in the Liver in Healthy Volunteers

Completed · Not applicable

Conditions studied: Efavirenz, Metabolism and Pharmacokinetics Changes

In brief

The purpose of this study is to see if administration of medicines and genetic differences affects the activity of a liver enzyme called CYP2B6 in healthy volunteers.

Key facts

Study ID

NCT01104376

Run by

Indiana University

People needed

61

Starts

2010-03-01

Expected to finish

2013-04-01

Last updated by the study team

2014-12-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subject between 18 and 55 years of age.
• Healthy individuals without any significant medical conditions as determined by a screening performed at University.
• Adherence to the study dietary and medication restrictions.
• Willingness to refrain from smoking or use of tobacco or marijuana one week before the start of the study and until completion of the study which will be a total of 17 days.
• Ability to commit the time requested for this study.

You may not qualify if…

• Underweight (weighs less than 50kg or 110lb) or over weight [body mass index (BMI) greater than 32].
• Drug or alcohol abuse (more than 3 alcoholic drinks per day on a regular basis).
• History of intolerance or allergic reaction (e.g. rash) to efavirenz and/or voriconazole.
• Significant health conditions such heart, gastrointestinal disorders, liver, or kidney diseases that may be exacerbated during the course of the study.
• History or current psychiatric illness (e.g. depression, anxiety, or nervousness).
• History or current eye sight disturbances (e.g. blurred vision).
• Serious infection within the last 2 weeks.
• Blood donation within the past two months.
• Screening results that do not fall in a healthy range.
• Regularly taking prescriptions (except hormonal agents, e.g. oral contraceptives), over-the-counter, herbal or dietary supplements, and alternative medications and are unable or unwilling to stop taking them one week before and during the study periods.
• Female with a positive pregnancy test.
• Female breastfeeding.
• Females of child-bearing potential who are unable or unwilling to either practice abstinence or use appropriate birth control up until the study completion, which will take a total of 17 days.
• Participation in a research study involving intensive blood sampling and/or have use study drugs in the last two months.
• Employed or student under supervision of any of the investigators of this study.
• Inability to state a good understanding of this study including risks and requirements, and inability to follow the rules of this study.

Where it is running

• Indiana University — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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