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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: MK-3102

Study type

Interventional

Funder types

Industry

Identifiers

NCT01767688

3102-031

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts 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