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VX-708

Phase 1

Acute Pain | Small molecule | Pain |Vertex Pharmaceuticals Incorporated|Last Updated: May 15, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05347394A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy ParticipantsPHASE1 COMPLETED 100Apr 8, 2022Apr 14, 2023May 15, 20231 United Kingdom
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Study Endpoints
Primary Endpoints
Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Day 1 up to Day 25
Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
From Day 1 up to Day 25
Secondary Endpoints
Parts A and B: Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-708
From Day 1 up to Day 25
Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test
From Day 1 up to Day 11
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: VX-708EXPERIMENTALParticipants will be randomized to receive a single dose of different dose levels of VX-708.
Part A: PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to VX-708.
Part B: VX-708EXPERIMENTALParticipants will be randomized to receive multiple doses of different dose levels of VX-708. The dose levels will be determined based on the data from Part A.
Part B: PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to VX-708.
Interventions
NameTypeDescription
VX-708DRUGSolution or suspension for oral administration.
PlaceboDRUGPlacebo matched to VX-708 for oral administration.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Male and female of non-childbearing potential are eligible * Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m\^2) * A total body weight greater than (\>) 50 kg Key Exclusion Criteria: * History of febrile illness or other acute illness within 14 day...

Countries:United Kingdom
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