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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: MK-3102

• Registration Number: NCT01767688
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Study Start: 2013-01-16
• Primary Completion: 2013-03-01
• Study Completion: 2013-03-07
• Results First Submitted: 2015-09-29
• Results First Submitted QC: 2015-09-29
• Results First Posted: 2015-10-29
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Hepatic Impairment Group	MK-3102	-
Healthy Matched Control Group	MK-3102	-

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)	Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)	Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
Number of Participants Experiencing Adverse Events (AEs)	Up to 14 days post-dose	An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Number of Participants Discontinued From Study Due to AEs	Up to 14 days post-dose	An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Plasma Concentration at 168 Hours After Dosing (C168h)	168 hours post-dose
Maximum Observed Plasma Concentration (Cmax)	Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
Time to Maximum Observed Plasma Drug Concentration (Tmax)	Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
Apparent Terminal Phase Half-life (t½)	Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose