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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767688
First Posted: January 14, 2013
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: MK-3102 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-3102 in Patients With Impaired Hepatic Function

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • Plasma Concentration at 168 Hours After Dosing (C168h) [ Time Frame: 168 hours post-dose ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 14 days post-dose ]
    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 [ Time Frame: Up to 14 days post-dose ]
    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.


Enrollment: 16
Actual Study Start Date: January 16, 2013
Study Completion Date: March 7, 2013
Primary Completion Date: March 1, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate Hepatic Impairment Group Drug: MK-3102
Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.
Experimental: Healthy Matched Control Group Drug: MK-3102
Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01767688     History of Changes
Other Study ID Numbers: 3102-031
First Submitted: January 10, 2013
First Posted: January 14, 2013
Results First Submitted: September 29, 2015
Results First Posted: October 29, 2015
Last Update Posted: June 29, 2017
Last Verified: June 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases