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

Influenza Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561807
• Other study ID #: VX11-787-101
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2012
• Last updated: August 31, 2016
• Start date: March 2012

Study information

• Verified date: August 2016
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza Virus
• Influenza, Human

Intervention

Drug:
• VX-787

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs.		up to 33 days	Yes
Secondary	Total tissue count and total mucus weight after viral inoculation		up to 10 days	No
Secondary	Sequence analysis of the relevant target region of influenza		up to 8 days	No
Secondary	Pharmacokinetic (PK) parameters of VX-787	As measured by AUC, Cmax, tmax	8 days	No
Secondary	Composite symptom score AUC		up to 8 days	No
Secondary	Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment		up to 8 days	No
Secondary	Duration of viral shedding by cell culture and/or RT-PCR		up to 8 days	No
Secondary	Peak viral shedding titer by cell culture and/or RT-PCR		up to 8 days	No
Secondary	Time to resolution from peak viral shedding by cell culture and/or RT-PCR		up to 8 days	No
Secondary	Time to peak of composite sympton score, duration, and time to resolution of composite score from peak		up to 8 days	No
Secondary	Peak severity of symptoms after viral inoculation		up to 8 days	No
Secondary	Duration of influenza-like illness after viral inoculation		up to 8 days	No