Healthy
Conditions
Brief summary
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time when MK-8527 is given alone and with the medication CBZ.
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria include, but are not limited to: * Is a healthy, adult, male or female of non-childbearing potential only, 18-55 years of age, inclusive * Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-8527 | Predose and at designated timepoints (up to 168 hours postdose) | Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma |
| Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-8527 | Predose and at designated timepoints (up to 168 hours postdose) | Blood samples will be collected to determine the AUC0-last of MK-8527 in plasma |
| Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8527 | Predose and at designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the AUC0-24 of MK-8527 in plasma |
| Area Under the Concentration-Time Curve from 0 to 168 hours (AUC0-168) of MK-8527 | Predose and at designated timepoints (up to 168 hours postdose) | Blood samples will be collected to determine the AUC0-168 of MK-8527 in plasma |
| Maximum Observed Plasma Concentration (Cmax) of MK-8527 | Predose and at designated timepoints (up to 168 hours postdose) | Blood samples will be collected to determine the Cmax of MK-8527 in plasma |
| Time to Maximum Observed Plasma Concentration (Tmax) of MK-8527 | Predose and at designated timepoints (up to 168 hours postdose) | Blood samples will be collected to determine the Tmax of MK-8527 in plasma |
| Apparent Terminal Half-Life (t1/2) of MK-8527 | Predose and at designated timepoints (up to 168 hours postdose) | Blood samples will be collected to determine the t1/2 of MK-8527 in plasma |
| Apparent Clearance (CL/F) of MK-8527 | Predose and at designated timepoints (up to 168 hours postdose) | Blood samples will be collected to determine the CL/F of MK-8527 in plasma |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 | Predose and at designated timepoints (up to 168 hours postdose) | Blood samples will be collected to determine the Vz/F of MK-8527 in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 60 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 30 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. |
Countries
United States
Outcome results
None listed