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VX-118

Phase 1

Cystic Fibrosis | Small molecule | Respiratory |Vertex Pharmaceuticals Incorporated|Last Updated: Jun 3, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06312787A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet FormulationPHASE1 COMPLETED 15Apr 2, 2024May 4, 2024Jun 3, 20241 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of VX-118
Pre-dose up to 192 hours Post-dose
Area Under the Concentration Versus Time Curve (AUC) of VX-118
Pre-dose up to 192 hours Post-dose
Secondary Endpoints
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
Day 1 up to Day 27
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTALParticipants will receive a single dose of VX-118 as a suspension in the fasted state in dosing period 1, followed by a single dose of VX-118 as tablets in the fasted state in dosing period 2, followed by a single dose of VX-118 as tablets in the fed state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Sequence 2EXPERIMENTALParticipants will receive a single dose of VX-118 as tablets in the fasted state in dosing period 1, followed by a single dose of VX-118 as tablets in the fed state in dosing period 2, followed by a single dose of VX-118 as a suspension in the fasted state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Sequence 3EXPERIMENTALParticipants will receive a single dose of VX-118 as tablets in the fed state in dosing period 1, followed by a single dose of VX-118 as a suspension in the fasted state in dosing period 2, followed by a single dose of VX-118 as tablets in the fasted state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Interventions
NameTypeDescription
VX-118DRUGTablets and Suspension for Oral Administration
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive * A total body weight greater than (\>) 50 kg * Participants of non-childbearing potential Key Exclusion Criteria: * History of febrile illness or other acute illness that has not f...

Countries:United States
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