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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919125
• Other study ID #: 1894-008
• Secondary ID: IDX-06A -008
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2013
• Last updated: January 25, 2016
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• IDX719
IDX719 supplied as 50 mg tablets.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)		Up to 6 days	No
Primary	Time to maximum plasma concentration (Tmax)		Up to 6 days	No
Primary	Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last)		Up to 6 days	No
Primary	AUC from time zero to infinity (AUC0-~)		Up to 6 days	No
Primary	AUC from time zero to 24 hours (AUC0-24h)		Up to 6 days	No
Primary	Plasma concentration 24 hours after dosing (C24h)		Up to 6 days	No
Primary	Apparent terminal elimination rate constant		Up to 6 days	No
Primary	Observed terminal half-life (T1/2)		Up to 6 days	No
Secondary	Percentage of participants experiencing serious adverse events (SAEs)		Up to 6 days	Yes
Secondary	Percentage of participants experiencing an adverse event (AE)		Up to 6 days	Yes
Secondary	Percentage of participants experiencing Grade 1-4 laboratory abnormalities		Up to 6 days	Yes