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Treatment with ARQ 197

Phase 1

Healthy | Unknown | Other |Merck & Company, Inc.|Last Updated: Jun 19, 2008

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00651638A Study of ARQ 197 in Healthy Volunteers to Assess the Pharmacokinetic (PK) Profile in Extensive and Poor Metabolizers as Defined by Cytochrome P450 2C19 (CYP 2C19) GenotypePHASE1 COMPLETED 17 — — Mar 1, 2008Jun 1, 2008Jun 19, 20081 United States
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Study Endpoints
Primary Endpoints
To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype
May 2008
Secondary Endpoints
To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197
May 2008
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Interventions
NameTypeDescription
Treatment with ARQ 197DRUGTreatment with ARQ 197
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject must provide written informed consent prior to any study related procedures * Subjects must be between the ages of 18 and 65 years old * Male participants must be surgically sterilized * Female participants must be surgically sterilized or post menopausal and must have...

Countries:United States
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