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INX-08189 Fasted

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jun 27, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01445795Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve SubjectsPHASE1 COMPLETED 50 — — Sep 1, 2011May 1, 2012Jun 27, 20162 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Change from baseline in HCV RNA 24 hours following the final dose of Study Drug (INX-08189/placebo)
24 hours following the final dose of Study Drug
Secondary Endpoints
Change in HCV RNA over time during the 7 days of dosing and during the follow-up period and the maximum change from baseline in HCV RNA.
HCV RNA will be measured at the following time points: Once each at Screening (Visit1), Study Day 10 (Visit 12), and Study Day 14 (Visit 13). Samples will be taken for HCV analysis pre-dose, and at 12, 24 and 48 hours after the first dose of Study Drug
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
200 mg INX-08189 FastedEXPERIMENTALCohort 1: 200 mg INX-08189 QD fasted for seven days
Placebo QD FastedPLACEBO_COMPARATORCohort 1: Placebo QD fasted for seven days
100 mg INX-08189 with RibavirinEXPERIMENTALCohort 2: 100 mg INX-08189 100 mg dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID, the AM dose will be taken 4 hours after INX-08189 so it may be taken with food)
Placebo QD dosed with ribavirinACTIVE_COMPARATORCohort 2: Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID)
100 mg INX-08189 with a low-fat mealEXPERIMENTALCohort 3: 100 mg INX-08189 with a low-fat meal QD x7 days
Placebo with low-fat mealPLACEBO_COMPARATORCohort 3: Placebo administered with a low-fat meal QD for 7 days
100 mg INX-08189 FastedEXPERIMENTALCohort 4: 100 mg INX-08189 BID fasted x7 days
Placebo BID FastedPLACEBO_COMPARATORCohort 4: Placebo BID fasted x7 days
Interventions
NameTypeDescription
200 mg INX-08189 FastedDRUG200 mg capsule INX-08189 fasted x7 days
Placebo QD FastedDRUGPlacebo capsule QD fasted x7 days
100 mg INX-08189 QDDRUG100 mg INX-08189 capsule QD x 7 days
Placebo QDDRUGPlacebo capsule Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID)
100 mg INX-08189 with low-fat mealDRUGINX-08189 100 mg capsule, with low-fat meal QD for seven days
Placebo with low-fat mealDRUGPlacebo capsule administered with a low-fat meal QD for seven days
100 mg INX-08189 BID FastedDRUG100 mg INX-08189 BID fasted x7 days
Placebo BID FastedDRUGPlacebo BID fasted x7 days
ribavirinDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: Screening visit (Visit 1), subject criteria: * Males and females, 18 to 65 years of age inclusive with a body mass index (BMI) of at least 18 kg/m2 but not exceeding 36 kg/m2; * Diagnosed with chronic HCV by at least 1 previous polymerase chain reaction (PCR) result prior to Vi...

Countries:United StatesPuerto Rico
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Competitive Landscape -Hepatitis C 11 trials
CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir
Abbott LaboratoriesABT2 — Undisclosed
AbbVie, Inc.ABBV1 — Undisclosed
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