Back to resultsStudy of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IDX719
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, HCV, treatment-naive
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A: Healthy Participants
Group B: HCV Participants
Arm Description
Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses.
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.
Outcomes
Primary Outcome Measures
Percentage of participants experiencing an adverse event (AE)
Percentage of participants experiencing serious AEs (SAEs)
Change in HCV ribonucleic acid (RNA)
Maximum plasma drug concentration (Cmax)
Time to maximum plasma drug concentration (Tmax)
Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t)
AUC from time zero to time 24 hours (AUC0-24h)
AUC from time zero to time infinity (AUC0-~)
Pre-dose trough plasma drug concentration (Ctrough)
Observed terminal plasma drug concentration half-life (t1/2)
Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses)
Apparent oral total volume of distribution (Vz/F)
Amount excreted in urine in each collection interval (Au)
Cumulative urine excretion (Au0-t)
Percentage of dose excreted in urine (% Dose excr)
Renal clearance (CLr)
Percentage of participants experiencing dose-limiting toxicity
Percentage of participants experiencing graded laboratory abnormalities
Secondary Outcome Measures
Full Information
NCT ID
NCT01508156
First Posted
January 9, 2012
Last Updated
April 24, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01508156
Brief Title
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
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, HCV, treatment-naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: Healthy Participants
Arm Type
Experimental
Arm Description
Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses.
Arm Title
Group B: HCV Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IDX719
Intervention Description
IDX719 liquid suspension (1 - 100 mg) taken by mouth.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo liquid suspension matching IDX719 taken by mouth.
Primary Outcome Measure Information:
Title
Percentage of participants experiencing an adverse event (AE)
Time Frame
Up to 14 days
Title
Percentage of participants experiencing serious AEs (SAEs)
Time Frame
Up to 14 days
Title
Change in HCV ribonucleic acid (RNA)
Time Frame
Baseline and Day 10
Title
Maximum plasma drug concentration (Cmax)
Time Frame
Pre-dose Day 1 to Day 13
Title
Time to maximum plasma drug concentration (Tmax)
Time Frame
Pre-dose Day 1 to Day 13
Title
Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t)
Time Frame
Pre-dose Day 1 to Day 13
Title
AUC from time zero to time 24 hours (AUC0-24h)
Time Frame
Pre-dose Day 1 to Day 1
Title
AUC from time zero to time infinity (AUC0-~)
Time Frame
Pre-dose Day 1 to Day 13
Title
Pre-dose trough plasma drug concentration (Ctrough)
Time Frame
Pre-dose Day 1
Title
Observed terminal plasma drug concentration half-life (t1/2)
Time Frame
Pre-dose Day 1 to Day 13
Title
Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses)
Time Frame
Pre-dose Day 1 to Day 13
Title
Apparent oral total volume of distribution (Vz/F)
Time Frame
Pre-dose Day 1 to Day 13
Title
Amount excreted in urine in each collection interval (Au)
Time Frame
Pre-dose Day 1 to Day 14
Title
Cumulative urine excretion (Au0-t)
Time Frame
Pre-dose Day 1 to Day 14
Title
Percentage of dose excreted in urine (% Dose excr)
Time Frame
Pre-dose Day 1 to Day 14
Title
Renal clearance (CLr)
Time Frame
Pre-dose Day 1 to Day 14
Title
Percentage of participants experiencing dose-limiting toxicity
Time Frame
Up to 8 days
Title
Percentage of participants experiencing graded laboratory abnormalities
Time Frame
Up to 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
24434503
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.
Results Reference
result
Learn more about this trial
Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)
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