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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

    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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Moderate Hepatic Impairment Group
Drug: MK-3102
Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.
EXPERIMENTAL: Healthy Matched Control Group
Drug: MK-3102
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

  1. CSR Synopsis

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.

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