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NCT05789173 · ClinicalTrials.gov registry record · Early Phase 1
Interaction of CYP2B6 Genotype and Efavirenz With Methadone and Tizanidine PK
A Early Phase 1 study of Drug-Drug Interaction, sponsored by Indiana University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05789173 is a Early Phase 1 study of Drug-Drug Interaction that is actively recruiting participants, run by Indiana University. The registered enrollment target is 60 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05789173, a Early Phase 1 study of Drug-Drug Interaction, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The main goal of this clinical study is to test how CYP2B6 genetic variations and efavirenz (cornerstone in HIV-1 therapy) dictate the disposition (PK) of CYP2B6 substrate (methadone) and PK and effect (PD) of CYP1A2 substrate (tizanidine). Specifically, the investigators will test whether efavirenz produces CYP2B6 genotype dependent unanticipated DDIs with CYP2B6 (methadone) and CYP1A2 (tizanidine), leading to lack of efficacy or increased toxicity. Healthy volunteers genotyped for CYP2B6\*6 and \*18 alleles will be grouped in to three genotype predicted phenotype groups: 20 normal metabolizer (NM) (CYP2B6\*1/\*1); 20 intermediate metabolizer (IM) (\*1/\*6, or \*1/\*18); and 20 poor metabolizer (PM) (\*6/\*6, \*6/\*18 or \*18/\*18). Each phenotype group will receive methadone and tizanidine (separated by a washout period) on two occasions: at baseline (control) and after treatment with efavirenz (600 mg/day for 17 days).
Conditions Studied
Interventions
- DRUG Methadone and Tizanidine
- DRUG Efavirenz, Methadone and Tizanidine
Study Locations (1)
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-10-06 |
| Est. Completion | 2026-04-15 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05789173
The ClinicalTrials.gov registry entry for NCT05789173 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Drug-Drug Interaction appearing as the primary indexed condition, and to 2 interventions - of which Methadone and Tizanidine is the first listed.
NCT05789173 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT05789173 about?
NCT05789173 is a clinical study titled "Interaction of CYP2B6 Genotype and Efavirenz With Methadone and Tizanidine PK". The main goal of this clinical study is to test how CYP2B6 genetic variations and efavirenz (cornerstone in HIV-1 therapy) dictate the disposition (PK) of CYP2B6 substrate (methadone) and PK and effect (PD) of CYP1A2 substrate (tizanidine). Specifically, the investigators will test whether efavirenz...
What is the current status of trial NCT05789173?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2023-10-06. Estimated completion is 2026-04-15.
What conditions does trial NCT05789173 study?
This clinical trial studies the following conditions: Drug-Drug Interaction.
What interventions are being tested in trial NCT05789173?
The interventions under investigation include: Methadone and Tizanidine (DRUG), Efavirenz, Methadone and Tizanidine (DRUG).
Who is sponsoring clinical trial NCT05789173?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05789173 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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