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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK-3102
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Moderate Hepatic Impairment Group

    Healthy Matched Control Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)

    Secondary Outcome Measures

    Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)
    Plasma Concentration at 168 Hours After Dosing (C168h)
    Maximum Observed Plasma Concentration (Cmax)
    Time to Maximum Observed Plasma Drug Concentration (Tmax)
    Apparent Terminal Phase Half-life (t½)
    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.
    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.

    Full Information

    First Posted
    January 10, 2013
    Last Updated
    August 9, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01767688
    Brief Title
    A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
    Official Title
    An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-3102 in Patients With Impaired Hepatic Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 16, 2013 (Actual)
    Primary Completion Date
    March 1, 2013 (Actual)
    Study Completion Date
    March 7, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Moderate Hepatic Impairment Group
    Arm Type
    Experimental
    Arm Title
    Healthy Matched Control Group
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    MK-3102
    Intervention Description
    Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.
    Primary Outcome Measure Information:
    Title
    Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)
    Time Frame
    Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
    Secondary Outcome Measure Information:
    Title
    Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)
    Time Frame
    Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
    Title
    Plasma Concentration at 168 Hours After Dosing (C168h)
    Time Frame
    168 hours post-dose
    Title
    Maximum Observed Plasma Concentration (Cmax)
    Time Frame
    Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
    Title
    Time to Maximum Observed Plasma Drug Concentration (Tmax)
    Time Frame
    Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
    Title
    Apparent Terminal Phase Half-life (t½)
    Time Frame
    Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
    Title
    Number of Participants Experiencing Adverse Events (AEs)
    Description
    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.
    Time Frame
    Up to 14 days post-dose
    Title
    Number of Participants Discontinued From Study Due to AEs
    Description
    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.
    Time Frame
    Up to 14 days post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=3102-031&kw=3102-031&tab=access

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

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