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TR-701 di- salt

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: May 3, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00876655Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid PhosphatePHASE1 COMPLETED 12Feb 1, 2009Mar 1, 2009May 3, 20161 United States
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Study Endpoints
Primary Endpoints
To evaluate the pharmacokinetics and relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule after single doses in normal healthy adult subjects
4 days
Secondary Endpoints
To determine the safety and tolerability of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult
4 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
free acidEXPERIMENTALTR-701 free acid phosphate powder in capsule formulation (equivalent to 150 mg TR-700)
di-sodium phosphate saltEXPERIMENTALOne 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)
Interventions
NameTypeDescription
TR-701 di-sodium phosphate saltDRUGOne 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)
TR-701 free acid phosphateDRUGOne 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700)
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs; * Females will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or ...

Countries:United States
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