A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-3102
Intervention description: Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        Impaired Hepatic Function Participants:

          -  A diagnosis of:

               1. Chronic (> 6 months) hepatic insufficiency

               2. 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