Completed

A Three-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-8742

What is being tested

Elbasvir

+ Elbasvir

Drug

Who is being recruted

Digestive System Diseases

+ Liver Diseases

+ Hepatic Insufficiency

From 18 to 75 Years

+27 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC

Last updated: October 25, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: March 6, 2013

Actual date on which the first participant was enrolled.

The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.

NCT01797536

Principal SponsorMerck Sharp & Dohme LLC

Last updated: October 25, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesLiver DiseasesHepatic Insufficiency

Criteria

9 inclusion criteria required to participate

Ability to swallow multiple capsules

Body mass index (BMI) 19 - 40 kg/m^2, inclusive

Females of childbearing potential must be either be sexually inactive (abstinent) for 14 days before study drug administration and throughout the study or be using an acceptable method of birth control

Females of non-childbearing potential must have undergone sterilization procedures at least 6 months before Study Day 1

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18 exclusion criteria prevent from participating

Blood donation > 500 mL or significant blood loss within 56 days before study drug administration

Currently use of any medication or substance which cannot be discontinued or maintained at a steady dose and regimen at least 14 days before study drug administration and throughout the study

Females who are pregnant or lactating

For healthy participants only, history of alcoholism within the past 2 years

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale

Group II

Experimental

Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale

Group III

Experimental

Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale

Group IV

Experimental

Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Call for Information (Investigational Site 0003)

Miami, United StatesOpen Call for Information (Investigational Site 0003) in Google Maps

Call for Information (Investigational Site 0001)

Orlando, United States

Completed2 Study Centers