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

NCT01767688 | Completed Phase 1 Results

• 1 other identifier: 3102-031
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Keywords

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

Study Arms (2)

Moderate Hepatic Impairment Group

EXPERIMENTAL

Drug: MK-3102

Healthy Matched Control Group

EXPERIMENTAL

Drug: MK-3102

Interventions

MK-3102 DRUG

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

Healthy Matched Control Group; Moderate Hepatic Impairment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Impaired Hepatic Function Participants:
• A diagnosis of:
• Chronic (\> 6 months) hepatic insufficiency
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Interventions

2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 14, 2013
• Study Start: January 16, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 7, 2013
• Last Updated: September 10, 2018
• Results First Posted: October 29, 2015

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share