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Human ADME

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Nov 15, 2019

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 Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01442831Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male SubjectsPHASE1 COMPLETED 6Sep 9, 2010Sep 22, 2010Nov 15, 20191 United States
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Study Endpoints
Primary Endpoints
To describe the single dose plasma PK of TR-700, the microbiologically active molecule
pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, then daily up to 312 hours post dose

To describe the single dose pharmacokinetics (Cmax, Tmax, AUC, t 1/2, CL/F) of total radioactivity in plasma, whole blood, urine and feces following oral (PO) administration of \[14C\] TR 701 in healthy adult male subjects

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Human ADMEEXPERIMENTAL -
Interventions
NameTypeDescription
Human ADMEDRUGOral single dose
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Males, between 18 and 50 years of age, inclusive. 2. Body mass index (BMI) of 20 kg/m2 to 29.9 kg/m2, inclusive. 3. In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs. Exclusion...

Countries:United States
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