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ALS-002200

Phase 1

Hepatitis C, Chronic | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Oct 31, 2017

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 Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01590407First in Human Study of ALS-002200; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1PHASE1 COMPLETED 71Dec 31, 2011Feb 28, 2013Oct 31, 20174 France, Moldova +1
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
up to Day 31

data points measured include patient reported adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results

Secondary Endpoints
Cmax
pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose
AUC
pre-dose and 0.25, 0.5, 1, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose
HCV ribonucleic acid (RNA) viral load reduction
Baseline to Day 31
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALS-002200EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ALS-002200DRUGALS-002200
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Subject has provided written consent. * In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned. * Subject is in good health as deemed ...

Countries:FranceMoldovaRomania
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