A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | January 2013 |
End Date: | April 2013 |
Contact: | Toll Free Number |
Phone: | 1888-577-8839 |
An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-3102 in Patients With Impaired Hepatic Function
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.
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
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