Skip to main content
OpenTrials
Completed

NCT Number: NCT01919125

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IDX719

Drug

IDX719 supplied as 50 mg tablets.

Other names: Samatasvir

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Up to 6 days

  2. Time to maximum plasma concentration (Tmax)

    Time frame: Up to 6 days

  3. Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last)

    Time frame: Up to 6 days

  4. AUC from time zero to infinity (AUC0-~)

    Time frame: Up to 6 days

  5. AUC from time zero to 24 hours (AUC0-24h)

    Time frame: Up to 6 days

  6. Plasma concentration 24 hours after dosing (C24h)

    Time frame: Up to 6 days

  7. Apparent terminal elimination rate constant

    Time frame: Up to 6 days

  8. Observed terminal half-life (T1/2)

    Time frame: Up to 6 days

Secondary outcomes

  1. Percentage of participants experiencing serious adverse events (SAEs)

    Time frame: Up to 6 days

  2. Percentage of participants experiencing an adverse event (AE)

    Time frame: Up to 6 days

  3. Percentage of participants experiencing Grade 1-4 laboratory abnormalities

    Time frame: Up to 6 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2013
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.