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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:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01767688
First received: January 10, 2013
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) from Hour 0 to Infinity (AUC0-∞) [ Time Frame: From predose (Hour 0) up to 168 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the concentration versus time curve from Hour 0 to 168 hours after dosing (AUC0-168h) [ Time Frame: From predose (Hour 0) up to 168 hours post dose ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) [ Time Frame: From predose (Hour 0) up to 168 hours post dose ] [ Designated as safety issue: No ]
  • Plasma concentration at 168 hours after dosing (C168h) [ Time Frame: 168 hours post dose ] [ Designated as safety issue: No ]
  • Time to maximum observed plasma drug concentration (Tmax) [ Time Frame: From predose (Hour 0) up to 168 hours post dose ] [ Designated as safety issue: No ]
  • Apparent terminal phase half-life (t½) [ Time Frame: From predose (Hour 0) up to 168 hours post dose ] [ Designated as safety issue: No ]
  • Number of participants experiencing adverse events (AEs) [ Time Frame: Up to 14 days post dose ] [ Designated as safety issue: Yes ]
  • Number of participants discontinued from study due to AEs [ Time Frame: Up to 14 days post dose ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: January 2013
Study Completion Date: March 2013
Primary Completion Date: March 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01767688     History of Changes
Other Study ID Numbers: 3102-031
Study First Received: January 10, 2013
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
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

ClinicalTrials.gov processed this record on May 19, 2013