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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01919125

Enrollment

Registered

2013-08-08

Start date

2013-08-31

Completion date

2014-02-28

Last updated

2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Keywords

Chronic hepatitis C, Hepatitis C virus, HCV

Brief summary

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.

Interventions

DRUGIDX719

IDX719 supplied as 50 mg tablets.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026