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

NCT ID: NCT01767688

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-16
• Study Completion Date: 2013-03-07

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate Hepatic Impairment Group

Group Type: EXPERIMENTAL

MK-3102

Intervention Type: DRUG

Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.

Healthy Matched Control Group

Group Type: EXPERIMENTAL

MK-3102

Intervention Type: DRUG

Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.

Interventions

MK-3102

Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

3102-031

Identifier Type: -

Identifier Source: org_study_id