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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-3102 in Patients With Impaired Hepatic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767688
• Other study ID #: 3102-031
• Status: Completed
• Phase: Phase 1
• Start date: January 16, 2013
• Est. completion date: March 7, 2013

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 7, 2013
• Est. primary completion date: March 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-8)		Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
Secondary	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
Secondary	Plasma Concentration at 168 Hours After Dosing (C168h)		168 hours post-dose
Secondary	Maximum Observed Plasma Concentration (Cmax)		Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
Secondary	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
Secondary	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
Secondary	Number of Participants Experiencing Adverse Events (AEs)	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.	Up to 14 days post-dose
Secondary	Number of Participants Discontinued From Study Due to AEs	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.	Up to 14 days post-dose