Hepatitis C, Chronic
Conditions
Keywords
Hepatitis C, HCV, treatment-naive
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.
Interventions
DRUGIDX719
IDX719 liquid suspension (1 - 100 mg) taken by mouth.
DRUGPlacebo
Placebo liquid suspension matching IDX719 taken by mouth.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants experiencing an adverse event (AE) | Up to 14 days |
| Percentage of participants experiencing serious AEs (SAEs) | Up to 14 days |
| Change in HCV ribonucleic acid (RNA) | Baseline and Day 10 |
| Maximum plasma drug concentration (Cmax) | Pre-dose Day 1 to Day 13 |
| Time to maximum plasma drug concentration (Tmax) | Pre-dose Day 1 to Day 13 |
| 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 |
| AUC from time zero to time 24 hours (AUC0-24h) | Pre-dose Day 1 to Day 1 |
| AUC from time zero to time infinity (AUC0-~) | Pre-dose Day 1 to Day 13 |
| Pre-dose trough plasma drug concentration (Ctrough) | Pre-dose 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 |
| Apparent oral total volume of distribution (Vz/F) | Pre-dose Day 1 to Day 13 |
| Amount excreted in urine in each collection interval (Au) | Pre-dose Day 1 to Day 14 |
| Cumulative urine excretion (Au0-t) | Pre-dose Day 1 to Day 14 |
| Percentage of dose excreted in urine (% Dose excr) | Pre-dose Day 1 to Day 14 |
| Renal clearance (CLr) | Pre-dose Day 1 to Day 14 |
| Percentage of participants experiencing dose-limiting toxicity | Up to 8 days |
| Percentage of participants experiencing graded laboratory abnormalities | Up to 14 days |
Outcome results
None listed