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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: Recruiting Early Phase 1 study of Drug-Drug Interaction, sponsored by Indiana University.
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, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
1. The primary PK interaction magnitude with R- and S-methadone will be quantified using the treatment:control \[+efavirenz:-efavirenz (baseline)\] ratios of the area under the time concentration curve to infinity (AUC0-∞) of S- and R-methadone. 2. The primary PK interaction magnitude with tizanidine will be quantified using the treatment:control \[+efavirenz:-efavirenz (baseline)\] ratios of the area under the time concentration curve to infinity (AUC0-∞) of tizanidine.
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 |
What NCT05789173 shows while recruiting
NCT05789173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Drug-Drug Interaction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05789173's enrollment target sits among peer trials
60 403rd of 2000 higher than 1,565 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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