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Tedizolid Formulation 1

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Dec 13, 2024

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
RandomizedCONTROLLED
Total Trials2
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06609161A Study to Compare Oral Formulations of Tedizolid Phosphate in Healthy Adults (MK-1986-044)PHASE1 COMPLETED 18Jul 16, 2024Aug 8, 2024Sep 27, 20241 United States
NCT06733688A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043)PHASE1 COMPLETED 36Mar 23, 2022Apr 15, 2022Dec 13, 20241 United States
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Study Endpoints
Primary Endpoints
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid
At designated time points (up to 3 days postdose)

Blood samples will be collected to determine the AUC0-Inf of tedizolid.

Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tedizolid
At designated time points (up to 3 days postdose)

Blood samples will be collected to determine the AUC0-Last of tedizolid.

Maximum Plasma Concentration (Cmax) of Tedizolid
At designated time points (up to 3 days postdose)

Blood samples will be collected to determine the Cmax of tedizolid.

Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) of Tedizolid
At designated time points (up to 3 days postdose)

Blood samples will be collected to determine the AUC0-t of tedizolid.

Secondary Endpoints
Number of Participants Who Experienced an Adverse Event (AE)
Up to approximately 2 weeks postdose
Number of Participants Who Discontinue Study Drug Due to an AE
Up to approximately 2 weeks postdose
Time to Maximum Plasma Concentration (Tmax) of Tedizolid
At designated time points (up to 3 days postdose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Tedizolid Phosphate Oral Formulation 1 (Reference)EXPERIMENTALParticipants will receive oral Formulation 1 (Reference).
Tedizolid Phosphate Oral Formulation 2 (Test)EXPERIMENTALParticipants will receive oral Formulation 2 (Test).
Interventions
NameTypeDescription
Tedizolid Phosphate Oral Formulation 1 (Reference)DRUGFormulation 1 (FM1) powder for oral suspension.
Tedizolid Phosphate Oral Formulation 2 (Test)DRUGFormulation 2 (FM2) powder for oral suspension.
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Eligibility Criteria
Age Range19 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2 Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a history of or presence of risk factors for Tors...

Countries:United States
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