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VTP-43742

Phase 1

Psoriasis | Small molecule | Dermatology |Syndax Pharmaceuticals, Inc.|Last Updated: Oct 30, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment114

FDA Designations

No designations recorded

Clinical trial landscape

VTP-43742 · 2 trials · 1 indication

Phase 1 2
NCT03724292An Ascending Multiple Dose Study With VTP-43742 in Healthy VolunteersPsoriasis
COMPLETED40 Analytics
NCT02555709An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers and Psoriatic PatientsPsoriasis
COMPLETED74 Analytics
PHASE1COMPLETED
An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers
PsoriasisUnlock trial analytics
PHASE1COMPLETED
An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers and Psoriatic Patients
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group
Study Day 1 to Day 17±2 (follow up)
safety data, including AEs, laboratory evaluations, ECG results, and vital signs assessments, will be listed by subject and summarized by dose and time point
10 days

Secondary Endpoints

Maximum plasma concentration (Cmax) in the healthy volunteer (Part 1) group
Day 1 and Day 10
Time to maximum plasma concentrations (tmax) in the healthy volunteer (Part 1) group
Day 1 and Day 10
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration (AUCt) in the healthy volunteer (Part 1) group
Day 1 and Day 10
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORDose-matched placebo administered as oral capsule(s) once daily
VTP-43742 Dose 1EXPERIMENTALVTP-43742 administered as oral capsule(s) once daily
VTP-43742 Dose 2EXPERIMENTALVTP-43742 administered as oral capsule(s) once daily
VTP-43742 Dose 3EXPERIMENTALVTP-43742 administered as oral capsule(s) once daily
VTP-43742 Dose 4EXPERIMENTALVTP-43742 administered as oral capsule(s) once daily
VTP-43742 Dose 5EXPERIMENTALVTP-43742 administered as oral capsule(s) once daily
Placebo 1PLACEBO_COMPARATORhealthy volunteers
VTP-43742 Dose 6EXPERIMENTALhealthy volunteers
VTP-43742 Dose 7EXPERIMENTALhealthy volunteers
Placebo 2PLACEBO_COMPARATORpsoriatic patients
VTP-43742 Dose 8EXPERIMENTALpsoriatic patients
VTP-43742 Dose 9EXPERIMENTALpsoriatic patients
VTP-43742 Dose 10EXPERIMENTALpsoriatic patients
VTP-43742 Dose 11EXPERIMENTALpsoriatic patients

Interventions

NameTypeDescription
PlaceboDRUGDose-matched placebo administered as oral capsule(s) once daily
VTP-43742DRUGVTP-43742 administered as oral capsule(s) once daily
Placebo 1DRUGPlacebo 1 matching VTP-43742 administered as an oral capsule once daily
Placebo 2DRUGPlacebo 2 matching VTP-43742 administered as an oral capsule once daily
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or females, 18 to 45 years of age, inclusive. * Body weight of at least 55 kg and body mass index of 18-32 kg/m2, inclusive. * Medically healthy with clinically insignificant screening results. * Women of child-bearing potential (WOCBP) AND men with partners who ...

Countries:United States
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Frequently asked questions about VTP-43742

What is VTP-43742 used for?

VTP-43742 is an investigational small molecule being developed for the treatment of psoriasis. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in clinical trials that include healthy volunteers and psoriatic patients.

Who makes VTP-43742?

VTP-43742 is being developed by Syndax Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SNDX. The company is conducting clinical trials for this investigational drug in the United States.

What phase is VTP-43742 in?

VTP-43742 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, both of which were randomized, double-blind, and placebo-controlled studies.

What clinical trials is VTP-43742 in?

VTP-43742 has been studied in two completed Phase 1 clinical trials. The first, NCT02555709, enrolled 74 participants and included healthy volunteers and psoriatic patients. The second, NCT03724292, enrolled 40 healthy volunteers. Both trials were conducted in the United States.

Is VTP-43742 the same as any other drug?

No alternative names for VTP-43742 have been disclosed. The drug is referred to by its code name VTP-43742 in clinical trial registries and by its developer, Syndax Pharmaceuticals.