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Mobocertinib

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Last Updated: Nov 3, 2023

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04056468A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic FunctionPHASE1 COMPLETED 24 — — Oct 9, 2020Feb 26, 2022Nov 3, 20232 United States
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Study Endpoints
Primary Endpoints
Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Cmax,u: Maximum Observed Unbound Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
λz: Terminal Elimination Rate Constant for Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose

Terminal elimination rate constant (λz) is a mathematical estimate calculated using log-linear regression of the terminal portions of a plasma concentration against time curve.

CL/F: Apparent Clearance After Extravascular Administration for Mobocertinib
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for Mobocertinib
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Vz,u/F: Apparent Volume of Distribution for Unbound Drug During the Terminal Disposition Phase After Extravascular Administration for Mobocertinib
Day 1 pre-dose and at multiple time points (up to 216 hours) post-dose
Secondary Endpoints
Plasma Protein Binding of Mobocertinib and Its Active Metabolites (AP32960 and AP32914)
Day 1 at multiple time points (up to 24 hours) post-dose
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Baseline up to 30 days after last dose of study drug (up to Day 32)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Moderate HI (Child-Pugh B): Mobocertinib 40 mgEXPERIMENTALMobocertinib 40 milligram (mg), capsule, orally, a single dose on Day 1.
Severe HI (Child-Pugh C): Mobocertinib 40 mgEXPERIMENTALMobocertinib 40 mg, capsule, orally, a single dose on Day 1.
Normal Hepatic Function: Mobocertinib 40 mgEXPERIMENTALMobocertinib 40 mg, capsule, orally, a single dose on Day 1.
Interventions
NameTypeDescription
MobocertinibDRUGMobocertinib capsule.
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Eligibility Criteria
Age Range18 Years — 79 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Inclusion Criteria for Healthy Participants 1. Continuous non-smoker or moderate smoker (less than or equal to (\<=) 10 cigarettes/day or the equivalent) before screening. Participant must agree to consume no more than 5 cigarettes or equivalent/day from the 7 days prior to mob...

Countries:United States
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