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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8507-019 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone + Ulonivirine | Experimental | Participants receive a stable dose of methadone orally from Day -14 through Day 16. Methadone is co-administered with one dose of oral ulonivirine on Day 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulonivirine | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone | The AUC0-24 of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | Up to 24 hours post-dose |
| Dose-Normalized AUC0-24 of S-Methadone | The AUC0-24 of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | Up to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone | The Cmax of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | Up to 24 hours post-dose |
| Dose-Normalized Plasma Concentration 24 Hours Postdose (C24) of R-Methadone |
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Inclusion Criteria
The main Inclusion Criteria include but are not limited to:
Exclusion Criteria
The main Exclusion Criteria include but are not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| C000723084 | ulonivirine |
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Methadone | Drug | Oral (per local guidelines) |
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The C24 of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). |
| 24 hours post-dose |
| Time to Maximum Plasma Concentration (Tmax) of R-Methadone | The Tmax of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | Up to 24 hours post-dose |
| Dose-Normalized Cmax of S-Methadone | The Cmax of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | Up to 24 hours post-dose |
| Dose-Normalized C24 of S-Methadone | The C24 of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | 24 hours post-dose |
| Tmax of S-Methadone | The Tmax of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | Up to 24 hours post-dose |
| Dose-Normalized AUC0-24 of Total Methadone | The AUC0-24 of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | Up to 24 hours post-dose |
| Dose-Normalized Cmax of Total Methadone | The Cmax of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | Up to 24 hours post-dose |
| Dose-Normalized C24 of Total Methadone | The C24 of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | 24 hours post-dose |
| Tmax of Total Methadone | The Tmax of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine). | Up to 24 hours post-dose |
| Number of Participants With Adverse Events (AEs) Following Methadone + Ulonivirine Coadministration | 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. | Up to 16 Days |
| Number of Participants Discontinuing Study Therapy Due to AEs Following Coadministration of Methadone and Ulonivirine | 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. | Up to 16 Days |