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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Zeruesenay Desta, Indiana University
ClinicalTrials.gov Identifier:
NCT01104376
First received: April 12, 2010
Last updated: April 8, 2013
Last verified: April 2013
History of Changes

April 12, 2010
April 8, 2013
March 2010
April 2011   (final data collection date for primary outcome measure)
Measure CYP2B6 activity in vivo, using the metabolism and pharmacokinetics of efavirenz as a probe. [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01104376 on ClinicalTrials.gov Archive Site
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Determine the Effects of Gene Differences and Voriconazole on Enzyme CYP2B6 Activity in the Liver in Healthy Volunteers
Effect of Cytochrome P450 2B6 Genetic Polymorphism and Voriconazole on CYP2B6 Activity in Healthy Volunteers

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.

The investigators will test the hypothesis that CYP2B6 genetic variants that show effects in vitro also influence the in vivo activity of CYP2B6 and its responsiveness to metabolic inhibition, using the metabolism of efavirenz (100 mg dose) as a marker of activity. The metabolism and pharmacokinetics of efavirenz will be determined in a total of 60 healthy volunteers with CYP2B6*1/*1, CYP2B6*1*6 and CYP2B6*6*6 at baseline (control) and after pretreatment with voriconazole.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
  • Metabolism
  • Pharmacokinetics
Drug: Efavirenz and voriconazole
In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily.
Other Names:
  • Efavirenz
  • Voriconazole
Experimental: CYP2B6
CYP2B6*1/*1 , CYP2B6*1*6 and CYP2B6*6*6
Intervention: Drug: Efavirenz and voriconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2013
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01104376
0808-16, R01GM078501
Yes
Zeruesenay Desta, Indiana University
Indiana University
  • National Institutes of Health (NIH)
  • National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Zeruesenay Desta, PhD IU Department of Medicine/Division of Clinical Pharmacology
Indiana University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP