Efavirenz for Drug Interaction

Phase < 1

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up methadone and tizanidine plasma concentrations (0-72 hours) will be determined before (control) and after pretreatment with efavirenz (600 mg/day) for 16 days and auc0-∞ will be estimated.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effect of a HIV-1 drug on how two other drugs, methadone and tizanidine, are processed by the body.

Who is the study for?

Healthy adults aged 18-65, who are non-smokers or willing to abstain from tobacco and marijuana, can join this trial. They must not take any interfering substances for two weeks before and during the study. Participants should have specific CYP2B6 genotypes (NM, IM, PM) without significant health issues as confirmed by screening tests.

What is being tested?

The study examines how genetic differences in CYP2B6 affect the body's handling of methadone and tizanidine when taken with efavirenz. It involves healthy volunteers grouped by their metabolism rate (normal, intermediate, poor), testing drug interactions at baseline and after taking efavirenz for 17 days.

What are the potential side effects?

Potential side effects may include digestive disorders that could alter drug absorption, low blood pressure risks with tizanidine use, allergic reactions to study drugs (efavirenz, tizanidine or methadone), and possible mental health impacts like depression or anxiety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ methadone and tizanidine plasma concentrations (0-72 hours) will be determined before (control) and after pretreatment with efavirenz (600 mg/day) for 16 days and auc0-∞ will be estimated.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~methadone and tizanidine plasma concentrations (0-72 hours) will be determined before (control) and after pretreatment with efavirenz (600 mg/day) for 16 days and auc0-∞ will be estimated.

This trial's timeline: 3 weeks for screening, Varies for treatment, and methadone and tizanidine plasma concentrations (0-72 hours) will be determined before (control) and after pretreatment with efavirenz (600 mg/day) for 16 days and auc0-∞ will be estimated. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Magnitude of effects of CYP2B6 genotype and multiple doses of efavirenz on the: 1) stereoselective disposition of methadone; and 2) disposition and pharmacodynamics of tizanidine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Efavirenz (treatment)Experimental Treatment1 Intervention

Each CYP2B6 normal metabolizer (NM) (\*1/\*1), intermediate metabolizer (IM) (\*1/\*6), and poor metabolizer (PM) (\*6/\*6, \*6/\*18, or \*18/\*18) group will be administered a single dose of methadone (10 mg) and a single dose of tizanidine (4 mg) orally simultaneously after 16-day oral treatment with 600 mg/day efavirenz

Group II: Baseline (control)Experimental Treatment1 Intervention

Each CYP2B6 normal metabolizer (NM) (\*1/\*1), intermediate metabolizer (IM) (\*1/\*6), and poor metabolizer (PM) (\*6/\*6, \*6/\*18, or \*18/\*18) group will receive a single dose of methadone (10 mg) and a single dose of tizanidine (4 mg) orally simultaneously at baseline (control).

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