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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indiana University
• Collaborators: National Institute of General Medical Sciences (NIGMS); National Institutes of Health (NIH)
• Treatments: Efavirenz; Voriconazole

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.