Phase 1
Completed N=14
Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045)
Source: ClinicalTrials.gov NCT02715700 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of R-Methadone — 55.8; 53.2 ng*hr/mL/mg
Summary
This study will evaluate the effects of multiple doses of doravirine (MK-1439) on the pharmacokinetics of methadone in participants requiring methadone maintenance therapy. The primary hypothesis is that area under the plasma concentration-time curve to 24 hours postdose (AUC0-24) of (R)-methadone is similar when a maintenance regimen of methadone is administered with or without multiple daily doses of doravirine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of R-Methadone |
55.8; 53.2 | — |
| PRIMARY Plasma Concentration at 24 Hours After Dosing (C24) of R-Methadone |
1.91; 1.82 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of R-Methadone |
3.41; 3.33 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of R-Methadone |
2.00; 2.01 | — |
| PRIMARY AUC0-24 of S-Methadone |
52.0; 50.8 | — |
| PRIMARY C24 of S-Methadone |
1.51; 1.47 | — |
| PRIMARY Cmax of S-Methadone |
3.77; 3.67 | — |
| PRIMARY Tmax of S-Methadone |
1.99; 2.00 | — |
| PRIMARY AUC0-24 of Total Methadone |
109; 105 | — |
| PRIMARY C24 of Total Methadone |
3.48; 3.34 | — |
| PRIMARY Cmax of Total Methadone |
7.19; 7.01 | — |
| PRIMARY Tmax of Total Methadone |
2.00; 2.01 | — |
Eligibility Criteria
Inclusion Criteria
- If female with reproductive potential: must demonstrate a serum β-human chorionic gonadotropin (β -hCG) level consistent with the nongravid state and agree to use (and/or have their partner use) two acceptable methods of birth control throughout the trial and until 2 weeks after the last dose of trial drug.
- If postmenopausal female: must be without menses for at least 1 year.
- If surgically sterile female: must have a status of post hysterectomy, oophorectomy or tubal ligation.
- Body Mass Index (BMI) of 18-35 kg/m^2 (inclusive).
- Able to comply with the smoking restrictions, including =5 prior to randomization.
Data sourced from ClinicalTrials.gov (NCT02715700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.