- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01767688
A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
August 9, 2018 updated by: Merck Sharp & Dohme LLC
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.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Moderate Hepatic Impairment Group
|
Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.
|
EXPERIMENTAL: Healthy Matched Control Group
|
Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
|
Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
|
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)
Time Frame: 168 hours post-dose
|
168 hours post-dose
|
|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
|
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)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
|
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)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose
|
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)
Time Frame: 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.
|
Up to 14 days post-dose
|
Number of Participants Discontinued From Study Due to AEs
Time Frame: 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.
|
Up to 14 days post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 16, 2013
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
March 7, 2013
Study Registration Dates
First Submitted
January 10, 2013
First Submitted That Met QC Criteria
January 10, 2013
First Posted (ESTIMATE)
January 14, 2013
Study Record Updates
Last Update Posted (ACTUAL)
September 10, 2018
Last Update Submitted That Met QC Criteria
August 9, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3102-031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaNot yet recruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on MK-3102
-
Merck Sharp & Dohme LLCCompletedType 2 Diabetes Mellitus | Chronic Renal Insufficiency
-
Merck Sharp & Dohme LLCCompleted
-
Azafaros A.G.Active, not recruitingNiemann-Pick Disease, Type C | GM2 GangliosidosisBrazil
-
Merck Sharp & Dohme LLCCompleted
-
Daewon Pharmaceutical Co., Ltd.Unknown
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompletedType 2 Diabetes Mellitus
-
Merck Sharp & Dohme LLCCompletedHypertension | Isolated Systolic Hypertension (ISH)
-
Merck Sharp & Dohme LLCTerminated