A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)
- Registration Number
- NCT07025551
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
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
- Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
Participants with Mild HI (Group 1) and Moderate HI (Group 2):
- Has mild or moderate hepatic impairment
- 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
The main exclusion criteria include but are not limited to the following:
All participants:
- Has a history of cancer (malignancy)
- Has positive results for human immunodeficiency virus (HIV)
- Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
Participants with Mild HI (Group 1) and Moderate HI (Group 2):
- With the exception of HI, has a history or presence of clinically significant medical or psychiatric condition or disease
- Is positive for Hepatitis B Virus (HBV)
- Is positive for Hepatitis C Virus (HCV)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mild Hepatic Impairment (Group 1) MK-8527 All participants will receive a single dose of MK-8527 on Day 1. Moderate Hepatic Impairment (Group 2) MK-8527 All participants will receive a single dose of MK-8527 on Day 1. Healthy (Group 3) MK-8527 All participants will receive a single dose of MK-8527 on Day 1.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.