N/A
Completed N=89
Determine the Effects of Gene Differences and Voriconazole on Enzyme CYP2B6 Activity in the Liver in Healthy Volunteers
Efavirenz, Metabolism and Pharmacokinetics Changes
Source: ClinicalTrials.gov NCT01104376 ↗
Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Measure Efavirenz Clearance — 45.51; 20.03 ml/min/kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure Efavirenz Clearance |
45.51; 20.03 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01104376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.