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VX-708

Phase 1

Acute Pain | Small molecule | Pain |Vertex Pharmaceuticals Incorporated|Last Updated: May 15, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

VX-708 · 2 trials · 2 indications

Phase 1 2
NCT05518734A Phase 1 Dose Escalation Study of VX-708 in Healthy ParticipantsPain
COMPLETED64 Analytics
NCT05347394A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy ParticipantsAcute Pain
COMPLETED100 Analytics
PHASE1COMPLETED
A Phase 1 Dose Escalation Study of VX-708 in Healthy Participants
Pain
NCT0551873464
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PHASE1COMPLETED
A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Participants
Acute Pain
NCT05347394100
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Study Endpoints

Primary Endpoints

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1 up to Day 30
Part A: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
Day 1 up to Day 30
Part A: Continuous Pulse Oximetry Monitoring as assessed by oxygen saturation for Cohort A4
Pre-dose up to 6 hours Post-dose
Part A: Infusion Nurses Society (INS) Visual Infusion Phlebitis (VIP) Score Monitoring
Day 1 up to Day 30
Part B: Area Under the Plasma Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-708 in the Absence or Presence of Itraconazole
Day 1 up to Day 16
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

Part A: Area Under the Plasma Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-708
Day 1 up to Day 14
Part A: Area Under the Concentration Versus Time Curve from the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Midazolam and 1-hydroxy-midazolam in the Absence or Presence of VX-708 (Cohort A4)
Day 1 up to Day 14
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1 up to Day 32
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: VX-708 (Cohort A1-A3)EXPERIMENTALParticipants will receive multiple doses of one of different dose levels of VX-708 under fasting condition.
Part A: PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to VX-708.
Part A: Midazolam With or Without VX-708 (Cohort A4)EXPERIMENTALParticipants will receive a single dose of Midazolam with or without VX-708 under fasting condition.
Part B: VX-708 With ItraconazoleEXPERIMENTALParticipants will receive a single dose of VX-708 in treatment period 1, followed by itraconazole, which will be dosed daily with a single dose of VX-708 administered in treatment period 2 under fasting conditions. A washout period of 6 days will be maintained between the 2 treatment periods.
Part A: VX-708EXPERIMENTALParticipants will be randomized to receive a single dose of different dose levels of 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 for intravenous (IV) administration.
ItraconazoleDRUGSolution for oral administration.
MidazolamDRUGSolution for oral administration.
PlaceboDRUGPlacebo matched to VX-708 for IV administration.
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Eligibility Criteria

Age Range18 Years to 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 StatesUnited Kingdom
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Competitive Landscape -Acute Kidney Injury 14 trials (matched to "Acute Pain")

CompanyTickerTrialsLead PhaseDrugs
Fresenius Medical Care AG Sponsored ADRFMS2PHASE3Dialysis
AstraZeneca PLCAZN1PHASE2AZD4144
CalciMedica, Inc.CALC1PHASE2Auxora
Talphera, Inc.TLPH1N/AUndisclosed
SeaStar Medical Holding CorporationICU2 - Undisclosed
Collegium Pharmaceutical, Inc.COLL1 - Flozin
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Frequently asked questions about VX-708

What is VX-708 used for?

VX-708 is an investigational small molecule being developed for the treatment of pain, including acute pain. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes VX-708?

VX-708 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX.

What phase is VX-708 in?

VX-708 is in Phase 1 clinical development. Two Phase 1 dose escalation studies have been completed, one in the United Kingdom and one in the United States, both involving healthy participants.

What clinical trials is VX-708 in?

VX-708 has been studied in two completed Phase 1 trials: NCT05347394, a dose escalation study in healthy participants in the United Kingdom, and NCT05518734, a dose escalation study in healthy participants in the United States.

Is VX-708 the same as any other drug?

No alternative names for VX-708 have been disclosed. It is identified solely by its code name VX-708 in clinical trial registries.