Healthy
Conditions
Brief summary
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.
Interventions
DRUGMK-1167
Administered via oral capsule per dosing regimen.
DRUGDiltiazem
Diltiazem hydrochloride administered at a dose of 240 mg QD via oral capsules.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting * Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2 * Able to swallow multiple capsules * In good health
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience one or more adverse events (AEs) | Up to approximately 99 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. |
| Number of participants who discontinue study intervention due to an AE | Up to approximately 85 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. |
| Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-1167 in plasma | Predose, and at designated timepoints up to 50 days post-dose | AUC0-inf of MK-1167 in plasma will be determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum concentration (Tmax) of MK-1167 in plasma | Predose, and at designated timepoints up to 50 days post-dose | Tmax of MK-1167 in plasma will be determined. |
| Apparent terminal half-life (t1/2) of MK-1167 in plasma | Predose, and at designated timepoints up to 50 days post-dose | t1/2 of MK-1167 in plasma will be determined. |
| Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-1167 in plasma | Predose, and at designated timepoints up to 50 days post-dose | AUC0-last of MK-1167 in plasma will be determined. |
| Apparent volume of distribution during terminal phase (Vz/F) of MK-1167 in plasma | Predose, and at designated timepoints up to 50 days post-dose | Vz/F of MK-1167 in plasma will be determined. |
| Apparent clearance (CL/F) of MK-1167 in plasma | Predose, and at designated timepoints up to 50 days post-dose | CL/F of MK-1167 in plasma will be determined. |
| Maximum concentration (Cmax) of MK-1167 in plasma | Predose, and at designated timepoints up to 50 days post-dose | Cmax of MK-1167 in plasma will be determined. |
| Concentration at hour 24 (C24) of MK-1167 in plasma | Predose, and at designated timepoints up to 24 hours post-dose | C24 of MK-1167 in plasma will be determined. |
Countries
United States
Outcome results
None listed