Recent Updates
Recently added Catalysts

VX-787

Phase 2

Influenza Virus | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Sep 2, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

VX-787 · 1 trial · 1 indication

Phase 2 1
NCT01561807A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza VirusInfluenza Virus
COMPLETED140 Analytics
PHASE2COMPLETED
A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza Virus
Influenza Virus
NCT01561807140
Unlock trial analytics

Study Endpoints

Primary Endpoints

The primary endpoint is viral AUC as calculated in cell culture of nasal swabs (quantitation of nasal swabs for viral infectivity by cell culture), from initiation of VX-787 treatment
up to 11 days

Secondary Endpoints

Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs.
up to 33 days
Total tissue count and total mucus weight after viral inoculation
up to 10 days
Sequence analysis of the relevant target region of influenza
up to 8 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
787 low doseEXPERIMENTALVX-787 low dose capsule, taken orally for 5 days
787 high doseEXPERIMENTALVX-787 high dose capsule, taken orally for 5 days
Placebo low doseEXPERIMENTALMatching placebo low dose capsule, taken orally for 5 days
Placebo high doseEXPERIMENTALMatching placebo high dose capsule, taken orally for 5 days

Interventions

NameTypeDescription
VX-787DRUG -
PlaceboDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Negative human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C(HCV) antibody screen * Have not been vaccinated for influenza virus since 2006 or had a known influenza-like illness in the current season (as determined in the medical history), defined as in the l...

Countries:United Kingdom
Unlock Eligibility Criteria

Frequently asked questions about VX-787

What is VX-787 used for?

VX-787 is an investigational small molecule being developed for the treatment of influenza virus infection. It is currently in Phase 2 clinical development. The drug has been studied in adult volunteers inoculated with live influenza virus in a clinical trial conducted in the United Kingdom.

Who makes VX-787?

VX-787 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical research on this investigational drug for influenza virus infection.

What phase is VX-787 in?

VX-787 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for its effects in adult volunteers inoculated with live influenza virus.

What clinical trials is VX-787 in?

VX-787 has been studied in one completed Phase 2 clinical trial, identified as NCT01561807. This trial enrolled 140 participants and was conducted in the United Kingdom. The study was randomized, double-blind, and controlled, and it involved adult volunteers aged 18 years and older.

Is VX-787 the same as pimodivir?

VX-787 is also known as pimodivir. This alternative name is used in scientific literature and clinical research. The drug is being developed by Vertex Pharmaceuticals for the treatment of influenza virus infection.