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

Phase 2

Completed

• Conditions: Influenza Virus
• Interventions: Drug: Placebo; Drug: VX-787

• Registration Number: NCT01561807
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Primary Completion: 2012-10
• Disposition First Submitted: 2014-01-08
• Disposition First Submitted QC: 2014-01-08
• Disposition First Posted: 2014-02-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo high dose	Placebo	Matching placebo high dose capsule, taken orally for 5 days
787 high dose	VX-787	VX-787 high dose capsule, taken orally for 5 days
787 low dose	VX-787	VX-787 low dose capsule, taken orally for 5 days
Placebo low dose	Placebo	Matching placebo low dose capsule, taken orally for 5 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	8 days	As measured by AUC, Cmax, tmax
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