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VX-840

Phase 1

APOL1-mediated Kidney Disease | Small molecule | Nephrology |Vertex Pharmaceuticals Incorporated|Last Updated: Dec 8, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

VX-840 · 1 trial · 1 indication

Phase 1 1
NCT05324410A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy ParticipantsAPOL1-mediated Kidney Disease
COMPLETED88 Analytics
PHASE1COMPLETED
A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants
APOL1-mediated Kidney DiseaseUnlock trial analytics

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

Secondary Endpoints

Parts A and B: Plasma Concentration of VX-840 Over Time
From Day 1 up to Day 14
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity [AUC(0 - inf)]
From Day 1 up to Day 14
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration [AUC(0-tlast)]
From Day 1 up to Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: VX-840EXPERIMENTALParticipants will be randomized to receive single dose of one of different dose levels of VX-840.
Part A: PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to VX-840.
Part B: VX-840EXPERIMENTALParticipants will be randomized to receive multiple doses of one of different dose levels of VX-840. The dose levels will be determined based on the data from Part A.
Part B: PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to VX-840.

Interventions

NameTypeDescription
VX-840DRUGSolution for oral administration.
PlaceboDRUGPlacebo matched to VX-840 for oral administration.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Female participants must be of non-childbearing potential * 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 days...

Countries:United States
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Frequently asked questions about VX-840

What is VX-840 used for?

VX-840 is an investigational small molecule being developed for APOL1-mediated Kidney Disease, a condition affecting kidney function. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes VX-840?

VX-840 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX.

What phase is VX-840 in?

VX-840 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 dose escalation study has been completed.

What clinical trials is VX-840 in?

VX-840 has one completed Phase 1 trial, NCT05324410, which evaluated safety and pharmacokinetics in healthy participants. The trial enrolled 88 participants in the United States and was placebo-controlled and double-blind.

Is VX-840 the same as any other drug?

No alternative names for VX-840 have been disclosed. It is identified solely by its investigational code name VX-840.