Clinical trial NCT01508156: Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)
Official title: A Phase I/IIa Study Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C
HCV
treatment-naive
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-01-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of participants experiencing an adverse event (AE)
timeFrame: Up to 14 days
measure: Percentage of participants experiencing serious AEs (SAEs)
timeFrame: Up to 14 days
measure: Change in HCV ribonucleic acid (RNA)
timeFrame: Baseline and Day 10
measure: Maximum plasma drug concentration (Cmax)
timeFrame: Pre-dose Day 1 to Day 13
measure: Time to maximum plasma drug concentration (Tmax)
timeFrame: Pre-dose Day 1 to Day 13
measure: Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t)
timeFrame: Pre-dose Day 1 to Day 13
measure: AUC from time zero to time 24 hours (AUC0-24h)
timeFrame: Pre-dose Day 1 to Day 1
measure: AUC from time zero to time infinity (AUC0-~)
timeFrame: Pre-dose Day 1 to Day 13
measure: Pre-dose trough plasma drug concentration (Ctrough)
timeFrame: Pre-dose Day 1
measure: Observed terminal plasma drug concentration half-life (t1/2)
timeFrame: Pre-dose Day 1 to Day 13
measure: Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses)
timeFrame: Pre-dose Day 1 to Day 13
measure: Apparent oral total volume of distribution (Vz/F)
timeFrame: Pre-dose Day 1 to Day 13
measure: Amount excreted in urine in each collection interval (Au)
timeFrame: Pre-dose Day 1 to Day 14
measure: Cumulative urine excretion (Au0-t)
timeFrame: Pre-dose Day 1 to Day 14
measure: Percentage of dose excreted in urine (% Dose excr)
timeFrame: Pre-dose Day 1 to Day 14
measure: Renal clearance (CLr)
timeFrame: Pre-dose Day 1 to Day 14
measure: Percentage of participants experiencing dose-limiting toxicity
timeFrame: Up to 8 days
measure: Percentage of participants experiencing graded laboratory abnormalities
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Vince B, Hill JM, Lawitz EJ, O'Riordan W, Webster LR, Gruener DM, Mofsen RS, Murillo A, Donovan E, Chen J, McCarville JF, Sullivan-Bolyai JZ, Mayers D, Zhou XJ. A randomized, double-blind, multiple-dose study of the pan-genotypic NS5A inhibitor samatasvir in patients infected with hepatitis C virus genotype 1, 2, 3 or 4. J Hepatol. 2014 May;60(5):920-7. doi: 10.1016/j.jhep.2014.01.003. Epub 2014 Jan 14.