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Calderasib OCT

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Feb 11, 2026

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 Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06942741A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011)PHASE1 COMPLETED 52 — — May 13, 2025Aug 4, 2025Feb 11, 20261 United States
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Study Endpoints
Primary Endpoints
Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Calderasib
At designated timepoints (up to approximately 2 days postdose)

Blood samples will be collected to determine the AUC0-last of calderasib.

Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Calderasib
At designated timepoints (up to approximately 2 days postdose)

Blood samples will be collected to determine the AUC0-inf of calderasib.

Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib
At designated timepoints (up to 24 hours postdose)

Blood samples will be collected to determine the AUC0-24 of calderasib.

Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Calderasib
At designated timepoints (up to approximately 2 days postdose)

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

Parts 1 and 2: Plasma Concentration of Calderasib at 24 Hours Postdose (C24)
At designated timepoints (up to 24 hours postdose)

Blood samples will be collected to determine the C24 of calderasib.

Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of Calderasib
At designated timepoints (up to approximately 2 days postdose)

Blood samples will be collected to determine the Tmax of calderasib.

Parts 1 and 2: Apparent Terminal Half-life (t1/2) of Calderasib
At designated timepoints (up to approximately 2 days postdose)

Blood samples will be collected to determine the t1/2 of calderasib.

Parts 1 and 2: Apparent Clearance (CL/F) of Calderasib
At designated timepoints (up to approximately 2 days postdose)

Blood samples will be collected to determine the CL/F of calderasib.

Parts 1 and 2: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
At designated timepoints (up to approximately 2 days postdose)

Blood samples will be collected to determine the Vz/F of calderasib.

Part 2: Plasma Lag Time (tlag) of Calderasib
At designated timepoints (up to approximately 2 days postdose)

Blood samples will be collected to determine the tlag of calderasib.

Secondary Endpoints
Parts 1 and 2: Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 7 weeks
Parts 1 and 2: Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 1 week
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part 1 Calderasib Treatment AEXPERIMENTALParticipants will be administered low dose calderasib as an oral-compressed tablet (OCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)
Part 1 Calderasib Treatment BEXPERIMENTALParticipants will be administered low dose calderasib as a film-coated tablet (FCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)
Part 2 Calderasib Treatment CEXPERIMENTALParticipants will be administered higher dose calderasib as a FCT on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)
Part 2 Calderasib Treatment DEXPERIMENTALParticipants will be administered higher dose calderasib as a FCT on Day 1 under fed conditions (after a high-fat meal)
Interventions
NameTypeDescription
Calderasib OCTDRUGOral tablet
Calderasib FCTDRUGOral tablet
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Has a body mass index ≥18.0 and ≤32.0 kg/m\^2 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history or presence of a clinically significant me...

Countries:United States
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