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VX-440

Phase 1

Cystic Fibrosis | Small molecule | Respiratory |Vertex Pharmaceuticals Incorporated|Last Updated: Apr 3, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

VX-440 · 1 trial · 1 indication

Phase 1 1
NCT03486236A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult SubjectsCystic Fibrosis
COMPLETED16 Analytics
PHASE1COMPLETED
A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs)
from baseline through safety follow-up visit (up to 29 days)

Secondary Endpoints

Maximum observed concentration (Cmax) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)
from Day 1 through Day 18
Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)
from Day 1 through Day 18
Observed pre-dose concentration (Ctrough) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)
from Day 1 through Day 18
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort C1EXPERIMENTAL -
Cohort C1: Triple PlaceboPLACEBO_COMPARATOR -
Cohort C2EXPERIMENTAL -
Cohort C2: Triple PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
VX-440DRUGVX-440 was administered in TC with TEZ and IVA.
TEZDRUGTEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)
IVADRUGIVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
Matched PlacebosDRUGPlacebos matched to VX-440, TEZ, and IVA.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Female subjects of non-childbearing potential only. * Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg. * Normal pulmonary function measurements, defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) both ...

Countries:United Kingdom
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Frequently asked questions about VX-440

What is VX-440 used for?

VX-440 is an investigational small molecule being developed for the treatment of cystic fibrosis. It is being studied in combination with tezacaftor and ivacaftor, which are other cystic fibrosis therapies. The drug is currently in Phase 1 clinical development.

Who makes VX-440?

VX-440 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company. Vertex is publicly traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of VX-440.

What phase is VX-440 in?

VX-440 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a Phase 1 clinical trial to evaluate its safety and pharmacokinetics in healthy adult subjects.

What clinical trials is VX-440 in?

VX-440 has one completed clinical trial, identified as NCT03486236. This was a Phase 1 study evaluating the safety and pharmacokinetics of VX-440 in combination with tezacaftor and ivacaftor in healthy adult subjects. The trial was conducted in the United Kingdom and enrolled 16 participants.

Is VX-440 the same as tezacaftor or ivacaftor?

No, VX-440 is a distinct investigational drug from tezacaftor and ivacaftor. In clinical trials, VX-440 is being studied in combination with tezacaftor and ivacaftor, which are separate medications used to treat cystic fibrosis. VX-440 is not an alternative name for either of these drugs.