A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza Virus

A Phase 2a, Randomized, Double-Blind,Placebo-Controlled Study to Investigate the Effects of VX-787 Administered to Adult Volunteers Experimentally Inoculated With Live Influenza Virus

The purpose of this study is to determine the antiviral activity and safety of VX-787 given to healthy adult volunteers that have been inoculated with the influenza virus.

Study Overview

• Status: Completed
• Conditions: Influenza Virus
• Intervention / Treatment: Drug: Placebo; Drug: VX-787

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 last 12 months before Screening

Exclusion Criteria:

• Subjects who are pregnant or nursing, or who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period (from at least 14 days before the first dose until 90 days of the last dose of study drug)
• Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness
• Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry
• Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral inoculation
• Intending to travel(to countries for which vaccinations are recommended or where high risk of infections exists)
• Subjects with a history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any etiology; any history during adulthood of asthma of any etiology, COPD, or any use of a bronchodilator or other asthma medication during adulthood
• Regular daily smokers
• History or evidence of autoimmune disease or known impaired immune responsiveness
• History of heart failure or any other severe cardiac abnormality including clinically significant arrhythmia
• Receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine, medication, or experimental respiratory viral challenge delivered directly to the respiratory tract within 1 year before viral inoculation
• Previous exposure to study drug or similar substance(s)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 787 low dose; VX-787 low dose capsule, taken orally for 5 days	Drug: VX-787
Experimental: 787 high dose; VX-787 high dose capsule, taken orally for 5 days	Drug: VX-787
Experimental: Placebo low dose; Matching placebo low dose capsule, taken orally for 5 days	Drug: Placebo
Experimental: Placebo high dose; Matching placebo high dose capsule, taken orally for 5 days	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pharmacokinetic (PK) parameters of VX-787	As measured by AUC, Cmax, tmax	8 days
Composite symptom score AUC		up to 8 days
Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment		up to 8 days
Duration of viral shedding by cell culture and/or RT-PCR		up to 8 days
Peak viral shedding titer by cell culture and/or RT-PCR		up to 8 days
Time to resolution from peak viral shedding by cell culture and/or RT-PCR		up to 8 days
Time to peak of composite sympton score, duration, and time to resolution of composite score from peak		up to 8 days
Peak severity of symptoms after viral inoculation		up to 8 days
Duration of influenza-like illness after viral inoculation		up to 8 days

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated
• Investigators: Study Director: Jose Trevejo, MD, PhD, Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Estimate): September 2, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: VX11-787-101