Healthy
Conditions
Brief summary
This study is designed to determine the effect of ulonivirine (MK-8507) on methadone in the body. Participants will take methadone alone and then methadone with ulonivirine to see if ulonivirine changes how the body processes methadone.
Interventions
DRUGUlonivirine
Oral Tablet
DRUGMethadone
Oral (per local guidelines)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
The main Inclusion Criteria include but are not limited to: * Is in good health * Has a body mass index (BMI) between \>18 and ≤40 kg/m\^2 * Is reliably participating in a methadone maintenance program for at least 2 months prior to Day 1 and is on a documented stable dose of methadone for at least 14 days prior to Day 1
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone | Up to 24 hours post-dose | The AUC0-24 of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Dose-Normalized AUC0-24 of S-Methadone | Up to 24 hours post-dose | The AUC0-24 of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone | Up to 24 hours post-dose | The Cmax of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Dose-Normalized Plasma Concentration 24 Hours Postdose (C24) of R-Methadone | 24 hours post-dose | The C24 of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Time to Maximum Plasma Concentration (Tmax) of R-Methadone | Up to 24 hours post-dose | The Tmax of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Dose-Normalized Cmax of S-Methadone | Up to 24 hours post-dose | The Cmax of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Dose-Normalized C24 of S-Methadone | 24 hours post-dose | The C24 of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Tmax of S-Methadone | Up to 24 hours post-dose | The Tmax of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Dose-Normalized AUC0-24 of Total Methadone | Up to 24 hours post-dose | The AUC0-24 of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Dose-Normalized Cmax of Total Methadone | Up to 24 hours post-dose | The Cmax of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Dose-Normalized C24 of Total Methadone | 24 hours post-dose | The C24 of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Tmax of Total Methadone | Up to 24 hours post-dose | The Tmax of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| Number of Participants With Adverse Events (AEs) Following Methadone + Ulonivirine Coadministration | Up to 16 Days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants experiencing an AE following coadministration of methadone and ulonivirine will be presented. |
| Number of Participants Discontinuing Study Therapy Due to AEs Following Coadministration of Methadone and Ulonivirine | Up to 16 Days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants discontinuing study therapy due to an AE following coadministration of methadone and ulonivirine will be presented. |
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed