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Treatment sequence AB

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Oct 16, 2012

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01253551VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and RaltegravirPHASE1 COMPLETED 21 — — Dec 1, 2010Apr 1, 2011Oct 16, 2012 - —
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Study Endpoints
Primary Endpoints
Blood levels of telaprevir and raltegravir when given alone versus when given together
Day 7 of Treatment A
Secondary Endpoints
Percentage of participants with a given adverse event as a measure of safety and tolerability
From screening to end of study
Clinical laboratory abnormalities as a measure of safety and tolerability
At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
Vital signs observed values and changes from baseline as a measure of safety and tolerability
At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
001EXPERIMENTALTreatment sequence AB Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6 with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10 with a morning dose of raltegravir and a morning and afternoon dose of telaprevir on Day 11.
002EXPERIMENTALTreatment sequence BA Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6 with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10 with a morning dose of raltegravir and a morning and afternoon dose of telaprevir on Day 11.
Interventions
NameTypeDescription
Treatment sequence ABDRUGTreatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
Treatment sequence BADRUGTreatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests at screening * A Body Mass Index of 18.0 to 30.0 kg/m2, extremes included * Women must be postmenopausal for at least 2 years, be surgically sterile and ...

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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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