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

NCT01919125 | Completed Phase 1

• 2 other identifiers: 1894-008IDX-06A -008
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C, Chronic

Keywords

Chronic hepatitis C; Hepatitis C virus; HCV

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• Observed terminal half-life (T1/2)

  Up to 6 days

Secondary Outcomes (3)

• Percentage of participants experiencing serious adverse events (SAEs)

  Up to 6 days

• 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

Study Arms (3)

Cohort 1: Child-Pugh Class A

EXPERIMENTAL

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

Cohort 2: Child-Pugh Class B

EXPERIMENTAL

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

Cohort 3: Child-Pugh Class C

EXPERIMENTAL

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

Interventions

IDX719 DRUG

IDX719 supplied as 50 mg tablets.

Also known as: Samatasvir

Cohort 1: Child-Pugh Class A; Cohort 2: Child-Pugh Class B; Cohort 3: Child-Pugh Class C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

samatasvir

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 8, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 26, 2016

Record last verified: 2016-01