Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)

Phase 1

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: IDX719; Drug: Placebo

• Registration Number: NCT01508156
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-11
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-24
• Last Update Posted: 2015-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• All Participants
• Is in good general health.
• Agrees to use double-barrier method of birth control for at least 90 days after the last dose of study drugs.
• HCV Participants
• Has documented GT1, GT2, or GT3 chronic HCV infection.

Exclusion Criteria

• All Participants
• Is pregnant or breastfeeding.

HCV Participants

• Has received prior HCV treatment.
• Is co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: HCV Participants	IDX719	Treatment-naive participants infected with HCV genotype (GT) 1, GT2, or GT3 take IDX719 (1 mg - 100 mg) or matching placebo as either 1 single dose or as 7 daily doses.
Group A: Healthy Participants	IDX719	Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses.
Group B: HCV Participants	Placebo	Treatment-naive participants infected with HCV genotype (GT) 1, GT2, or GT3 take IDX719 (1 mg - 100 mg) or matching placebo as either 1 single dose or as 7 daily doses.
Group A: Healthy Participants	Placebo	Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses.

Primary Outcome Measures

Name	Time	Method
AUC from time zero to time 24 hours (AUC0-24h)	Pre-dose Day 1 to Day 1
Observed terminal plasma drug concentration half-life (t1/2)	Pre-dose Day 1 to Day 13
Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses)	Pre-dose Day 1 to Day 13
Percentage of participants experiencing dose-limiting toxicity	Up to 8 days
Percentage of participants experiencing an adverse event (AE)	Up to 14 days
Percentage of participants experiencing serious AEs (SAEs)	Up to 14 days
Time to maximum plasma drug concentration (Tmax)	Pre-dose Day 1 to Day 13
Pre-dose trough plasma drug concentration (Ctrough)	Pre-dose Day 1
Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t)	Pre-dose Day 1 to Day 13
Change in HCV ribonucleic acid (RNA)	Baseline and Day 10
Maximum plasma drug concentration (Cmax)	Pre-dose Day 1 to Day 13
Percentage of dose excreted in urine (% Dose excr)	Pre-dose Day 1 to Day 14
Percentage of participants experiencing graded laboratory abnormalities	Up to 14 days
AUC from time zero to time infinity (AUC0-~)	Pre-dose Day 1 to Day 13
Apparent oral total volume of distribution (Vz/F)	Pre-dose Day 1 to Day 13
Cumulative urine excretion (Au0-t)	Pre-dose Day 1 to Day 14
Renal clearance (CLr)	Pre-dose Day 1 to Day 14
Amount excreted in urine in each collection interval (Au)	Pre-dose Day 1 to Day 14