A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)

Study Overview
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Brief Summary
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This study will investigate and compare the pharmacokinetics of a single 25-mg dose of MK-3102 in participants with moderate hepatic impairment and matched healthy participants. The primary hypothesis is that in participants with moderately impaired hepatic function, the area under the concentration-time curve from time zero to infinity (AUC0-∞) is similar to that observed in healthy matched control participants following a single 25 mg oral dose of MK-3102. Specifically, the true ratio (moderately impaired hepatic function patients/healthy matched control subjects) of geometric means for AUC0-∞ is no greater than 2.

Official Title
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An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-3102 in Patients With Impaired Hepatic Function

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: MK-3102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Impaired Hepatic Function Participants: A diagnosis of: Chronic (> 6 months) hepatic insufficiency Stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology Score on the Child-Pugh Scale of 7 to 9 (moderate hepatic insufficiency) Estimated creatinine clearance (CLCr) > 60 mL/min or glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m^2 Both Impaired Hepatic Function and Healthy Participants: In general good health Continuous non-smokers or moderate smokers for at least 3 months prior to study start Body Mass Index ≤39 kg/m^2 Females of reproductive potential must have a negative pregnancy test and agree to use acceptable birth control method(s) or remain sexually inactive throughout study Non-vasectomized male patients must agree to use acceptable birth control method(s) or abstain from sexual intercourse during the trial and for 3 months after the study Exclusion Criteria: Healthy Participants: History or presence of alcoholism within the past 2 years Presence of hepatitis B virus (HBV) or hepatitis virus C (HVC) Both Impaired Hepatic Function and Healthy Participants: History or presence of drug abuse within the past 2 years History or presence of human immunodeficiency virus (HIV) History or presence of significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (other than hepatic impairment), endocrine, immunologic, dermatologic, or neurological disease Use of any medication or substance (including prescription or over the counter, health supplements, natural or herbal supplements) which cannot be discontinued at least 14 days prior to the study start and throughout the study Has been on a special diet within 28 days prior to the study start Blood donation within 56 days or plasma donation within 7 days prior to study start Participation in another clinical trial within 28 days of study start Women who are pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Hepatic Impairment Group<br> | Drug: MK-3102<br>* Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.<br>|
| Experimental: Healthy Matched Control Group<br> | Drug: MK-3102<br>* Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞) |  | Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h) |  | Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose | 
| Plasma Concentration at 168 Hours After Dosing (C168h) |  | 168 hours post-dose | 
| Maximum Observed Plasma Concentration (Cmax) |  | Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose | 
| Time to Maximum Observed Plasma Drug Concentration (Tmax) |  | Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose | 
| Apparent Terminal Phase Half-life (t½) |  | Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose | 
| Number of Participants Experiencing Adverse Events (AEs) | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to 14 days post-dose | 
| Number of Participants Discontinued From Study Due to AEs | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to 14 days post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases