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CMX157

Phase 1

Healthy | Small molecule | Other |Jazz Pharmaceuticals plc|Last Updated: Jul 4, 2011

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01080820A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy VolunteersPHASE1 COMPLETED 36Jun 1, 2010Dec 1, 2010Jul 4, 20111 United States
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Study Endpoints
Primary Endpoints
Adverse events (AEs), absolute values and changes over time of clinical chemistry including troponin, hematology, and urinalysis, vital signs (blood pressure (BP) and heart rate), electrocardiogram
dosing-28 days post-dose
Secondary Endpoints
CMX157 PK parameters: AUC(0-∞), AUC(0-t), Cmax, C12, and C24 following single dose administration.
dosin - 28 days post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
Placebo + VireadPLACEBO_COMPARATOR -
VireadACTIVE_COMPARATOR -
CMX157 + VireadEXPERIMENTAL -
Interventions
NameTypeDescription
CMX157DRUGOne single oral dose of CMX157 will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the CMX157 dose.
PlaceboDRUGOne single oral dose of placebo will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the placebo dose.
VireadDRUGOne single oral dose of 300mg Viread.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1\. Males or females of non-childbearing potential, 18 to 55 years of age. Males must be able and willing to use adequate contraceptive methods throughout the study. Exclusion Criteria: 1. Currently nursing females, pregnant females, or females of child-bearing potential. 2. H...

Countries:United States
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