Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)

January 25, 2016 updated by: Merck Sharp & Dohme LLC

A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of IDX719 in Subjects With Normal and Impaired Hepatic Function

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Read and sign the written informed consent form (ICF) after the nature of the study has been fully explained.
  • All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.
  • Male subjects have agreed not to donate sperm from Day -1 through 90 days after the last dose of study drug.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Other clinically significant medical conditions or laboratory abnormalities

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Child-Pugh Class A
Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
Drug: IDX719
IDX719 supplied as 50 mg tablets.
Other Names:
  • Samatasvir
Experimental: Cohort 2: Child-Pugh Class B
Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
Drug: IDX719
IDX719 supplied as 50 mg tablets.
Other Names:
  • Samatasvir
Experimental: Cohort 3: Child-Pugh Class C
Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
Drug: IDX719
IDX719 supplied as 50 mg tablets.
Other Names:
  • Samatasvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: Up to 6 days
Up to 6 days
Time to maximum plasma concentration (Tmax)
Time Frame: Up to 6 days
Up to 6 days
Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last)
Time Frame: Up to 6 days
Up to 6 days
AUC from time zero to infinity (AUC0-~)
Time Frame: Up to 6 days
Up to 6 days
AUC from time zero to 24 hours (AUC0-24h)
Time Frame: Up to 6 days
Up to 6 days
Plasma concentration 24 hours after dosing (C24h)
Time Frame: Up to 6 days
Up to 6 days
Apparent terminal elimination rate constant
Time Frame: Up to 6 days
Up to 6 days
Observed terminal half-life (T1/2)
Time Frame: Up to 6 days
Up to 6 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants experiencing serious adverse events (SAEs)
Time Frame: Up to 6 days
Up to 6 days
Percentage of participants experiencing an adverse event (AE)
Time Frame: Up to 6 days
Up to 6 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities
Time Frame: Up to 6 days
Up to 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

August 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 8, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1894-008
  • IDX-06A -008

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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