Hepatic Impairment, Healthy Participants
Conditions
Brief summary
The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic \[PK\] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.
Interventions
DRUGMK-8527
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: All participants: * Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing * Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m\^2 Participants with Mild HI (Group 1) and Moderate HI (Group 2): * Has mild or moderate hepatic impairment * Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology * Is generally in good health with the exception of HI Healthy Control Participants (Group 3): \- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration versus 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 post dose | Plasma samples will be collected at pre-specified timepoints to determine the AUC0-last of MK-8527. |
| Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-8527 | Predose and at designated timepoints up to 168 hours post dose | Plasma samples will be collected at pre-specified timepoints to determine the AUC0-inf of MK-8527. |
| Maximum Observed Concentration (Cmax) of MK-8527 | Predose and at designated timepoints up to 168 hours post dose | Plasma samples will be collected at pre-specified timepoints to determine the Cmax of MK-8527. |
| Time to Maximum Concentration (Tmax) of MK-8527 | Predose and at designated timepoints up to 168 hours post dose | Plasma samples will be collected at pre-specified timepoints to determine the Tmax of MK-8527. |
| Apparent Terminal Half-life (t1/2) of MK-8527 | Predose and at designated timepoints up to 168 hours post dose | Plasma samples will be collected at pre-specified timepoints to determine the t1/2 of MK-8527. |
| Apparent Clearance (CL/F) of MK-8527 | Predose and at designated timepoints up to 168 hours post dose | Plasma samples will be collected at pre-specified timepoints to determine the CL/F of MK-8527. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 | Predose and at designated timepoints up to 168 hours post dose | Plasma samples will be collected at pre-specified timepoints to determine the Vz/F of MK-8527. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 29 days | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Number of Participants Who Discontinue Study Due to an AE | Up to approximately 29 days | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| AUC0-inf of MK-8527-triphosphate (TP) in peripheral blood mononuclear cell (PBMCs) | Predose and at designated timepoints up to 672 hours post dose | Blood samples will be collected to determine the AUC0-inf of MK-8527-TP. |
| Area under the concentration versus time curve from 0 to 672 hours after dosing (AUC0-672hrs) of MK-8527-TP in PBMCs | At designated timepoints pre dose and up to approximately 672 hours post dose | Blood samples will be collected to determine the AUC0-672 of MK-8527-TP. |
| Cmax of MK-8527-TP in PBMCs | Predose and at designated timepoints up to 672 hours post dose | Blood samples will be collected to determine the Cmax of MK-8527-TP. |
| Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs | Predose and at designated timepoints up to 672 hours post dose | Blood samples will be collected to determine the C672 of MK-8527-TP. |
| Tmax of MK-8527-TP in PBMCs | Predose and at designated timepoints up to 672 hours post dose | Blood samples will be collected to determine the Tmax of MK-8527-TP. |
| T1/2 of MK-8527-TP in PBMCs | Predose and at designated timepoints up to 672 hours post dose | Blood samples will be collected to determine the Tmax of MK-8527-TP. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed