Clinical trial NCT01767688: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-01-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)
timeFrame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
Secondary outcomes:
measure: Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)
timeFrame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
measure: Plasma Concentration at 168 Hours After Dosing (C168h)
timeFrame: 168 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
measure: Time to Maximum Observed Plasma Drug Concentration (Tmax)
timeFrame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
measure: Apparent Terminal Phase Half-life (t½)
timeFrame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to 14 days post-dose
measure: Number of Participants Discontinued From Study Due to AEs
timeFrame: Up to 14 days post-dose
Other outcomes:
Locations:
Study officials:
References: