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NCT02401256 · ClinicalTrials.gov registry record · Phase 4
CYP2B6 Genetics and Drug Interactions in Healthy Volunteers
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT02401256: Completed Phase 4 study, sponsored by Indiana University.
NCT02401256 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 70 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02401256, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study Summary
The CYP2B6 enzyme metabolizes a growing number of clinically important drugs such as the anti-HIV drug efavirenz, but its activity in the liver is highly variable, which may lead to failure of therapy or toxicity and unpredictable drug interactions. Genetic and several nongenetic factors affect the activity of CYP2B6. The goal of this study is to determine the impact of simultaneous autoinhibition/autoinduction and CYP2B6 genetics on CYP2B6 activity, efavirenz exposure and efavirenz-mediated drug interactions. The pharmacokinetics and drug interactions will be determined on three occasions in a total of 60 healthy volunteers. The whole study will have 4 phases. A) Phase 1 (baseline control): using selective probe substrates, the baseline activities of CYP2B6 (bupropion), CYP2C8 (montelukast) and OATP1B1 (rosuvastatin) are determined. B) Phase 2 (inhibition): the metabolism and pharmacokinetics of a single 600 mg oral dose of efavirenz) and the activities of CYP2B6, CYP2C8 and OATP1B1 (inhibition) are determined. C) Phase 3 (treatment phase): After completing phase 2, subjects take 600 mg/day efavirenz at home for 17 days. C) Phase 4 (induction and inhibition): At the end of phase 3, steady state metabolism and pharmacokinetics of efavirenz and the activities of CYP2B6, CYP2C8 and OATP1B1 will be determined. Efavirenz serves as a model substrate, inhibitor and inducer of CYP2B6 (and other drug disposition proteins). Bupropion 4-hydroxylation is an alternative in vivo probe of CYP2B6 activity and will be studied here in addition to the metabolism and pharmacokinetics of efavirenz.
Primary Outcome
After the samples collection, blood from phase 2 and phase 4 were used to perform the quantification of Efavirenz in plasma. The composite of the efavirenz concentration (blood collection between 0 to 120 hrs) were used to calculate the area under the plasma concentration time curve (AUC0-inf for single dose and AUC0-24 for multiple dose) of efavirenz.
Interventions
- DRUG Montelukast
- DRUG Rosuvastatin
- DRUG Bupropion
- DRUG Efavirenz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-05-31 |
| Phase | Phase 4 |
What the finished NCT02401256 record still lists
NCT02401256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 4 interventions - of which Montelukast is the first listed.
NCT02401256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02401256 about?
NCT02401256 is a clinical study titled "CYP2B6 Genetics and Drug Interactions in Healthy Volunteers". The CYP2B6 enzyme metabolizes a growing number of clinically important drugs such as the anti-HIV drug efavirenz, but its activity in the liver is highly variable, which may lead to failure of therapy or toxicity and unpredictable drug interactions. Genetic and several nongenetic factors affect the ...
What is the current status of trial NCT02401256?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2013-07. Estimated completion is 2016-05-31.
What interventions are being tested in trial NCT02401256?
The interventions under investigation include: Montelukast (DRUG), Rosuvastatin (DRUG), Bupropion (DRUG), Efavirenz (DRUG).
Who is sponsoring clinical trial NCT02401256?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02401256's enrollment target sits among peer trials
70 1043rd of 2000 higher than 931 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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