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IDX719

Phase 1

Hepatitis C, Chronic | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jan 26, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials3
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01919125Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)PHASE1 COMPLETED 36 — — Aug 1, 2013Feb 1, 2014Jan 26, 2016 - —
NCT01907724Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)PHASE1 COMPLETED 34 — — May 1, 2013Aug 1, 2013Jan 26, 2016 - —
NCT01508156Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)PHASE1 COMPLETED 130 — — Jan 1, 2012Jul 1, 2012Apr 27, 2015 - —
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Study Endpoints
Primary Endpoints
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
Observed maximum plasma drug concentration (Cmax)
Up to 14 days
Time to maximum concentration (Tmax)
Up to 14 days
Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)
Up to 14 days
Predose trough concentration (Ctrough)
Up to 14 days
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
Secondary Endpoints
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1: Child-Pugh Class AEXPERIMENTALParticipants 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.
Cohort 2: Child-Pugh Class BEXPERIMENTALParticipants 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.
Cohort 3: Child-Pugh Class CEXPERIMENTALParticipants 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.
IDX719 + RTVEXPERIMENTALParticipants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
Simeprevir/TMC647055 + RTVEXPERIMENTALParticipants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
Group A: Healthy ParticipantsEXPERIMENTALHealthy 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 ParticipantsEXPERIMENTALTreatment-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.
Interventions
NameTypeDescription
IDX719DRUGIDX719 supplied as 50 mg tablets.
SimeprevirDRUGSimeprevir will be supplied as 75 mg capsules for oral administration.
TMC647055DRUGTMC647055 will be supplied as 150 mg capsules for oral administration.
RTVDRUGRTV will be supplied as 80 mg/mL solution for oral administration.
PlaceboDRUGPlacebo liquid suspension matching IDX719 taken by mouth.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * 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 d...

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