CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 61 enrolled
Drug / intervention
Efavirenz +1 moredrug
Likely dose
Efavirenz 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01104376
NCT01104376N/ACompleted

Effect of Cytochrome P450 2B6 Genetic Polymorphism and Voriconazole on CYP2B6 Activity in Healthy Volunteers

Indiana University·interventional·Posted Apr 15, 2010·Updated Dec 17, 2014

In Brief

A clinical study evaluating Efavirenz and voriconazole for Efavirenz, Metabolism and Pharmacokinetics Changes. Completed, enrolled 61 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2010
Enrollment StartMar 1, 2010
Primary CompletionApr 1, 2011
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.2 years ago

Interventions

Efavirenzdrug

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.

voriconazoledrug

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.