Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-1167-006 | Other Identifier | MSD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study this study is to learn about the safety of MK-1167 and if people tolerate it. Researchers will compare what happens to MK-1167 in the body when it is given with and without another medicine called diltiazem.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-1167 Period 1 | Experimental | On Day 1 a single dose of MK-1167 will be administered. |
|
| MK-1167 Period 2 | Experimental | There will be a washout of at least 35 days between MK-1167 dosing in Period 1 and the first diltiazem dose in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 49 consecutive days with a single dose of MK-1167 coadministered on Day 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1167 | Drug | Administered via oral capsule per dosing regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience one or more adverse events (AEs) | 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. | Up to approximately 99 days |
| Number of participants who discontinue study intervention due to an AE | 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. | Up to approximately 85 days |
| Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-1167 in plasma | AUC0-inf of MK-1167 in plasma will be determined. | Predose, and at designated timepoints up to 50 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-1167 in plasma | AUC0-last of MK-1167 in plasma will be determined. | Predose, and at designated timepoints up to 50 days post-dose |
| Maximum concentration (Cmax) of MK-1167 in plasma |
Not provided
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion (Site 0002) | Lincoln | Nebraska | 68502 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004110 | Diltiazem |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Diltiazem | Drug | Diltiazem hydrochloride administered at a dose of 240 mg QD via oral capsules. |
|
Cmax of MK-1167 in plasma will be determined. |
| Predose, and at designated timepoints up to 50 days post-dose |
| Concentration at hour 24 (C24) of MK-1167 in plasma | C24 of MK-1167 in plasma will be determined. | Predose, and at designated timepoints up to 24 hours post-dose |
| Time to maximum concentration (Tmax) of MK-1167 in plasma | Tmax of MK-1167 in plasma will be determined. | Predose, and at designated timepoints up to 50 days post-dose |
| Apparent terminal half-life (t1/2) of MK-1167 in plasma | t1/2 of MK-1167 in plasma will be determined. | Predose, and at designated timepoints up to 50 days post-dose |
| Apparent clearance (CL/F) of MK-1167 in plasma | CL/F of MK-1167 in plasma will be determined. | Predose, and at designated timepoints up to 50 days post-dose |
| Apparent volume of distribution during terminal phase (Vz/F) of MK-1167 in plasma | Vz/F of MK-1167 in plasma will be determined. | Predose, and at designated timepoints up to 50 days post-dose |