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

NCT ID: NCT01561807

Last Updated: 2016-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31

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.

Conditions

Influenza Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

787 low dose

VX-787 low dose capsule, taken orally for 5 days

Group Type: EXPERIMENTAL

VX-787

Intervention Type: DRUG

787 high dose

VX-787 high dose capsule, taken orally for 5 days

Group Type: EXPERIMENTAL

VX-787

Intervention Type: DRUG

Placebo low dose

Matching placebo low dose capsule, taken orally for 5 days

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo high dose

Matching placebo high dose capsule, taken orally for 5 days

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Interventions

VX-787

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Trevejo, MD, PhD

Role: STUDY_DIRECTOR

Vertex Pharmaceuticals Incorporated

Locations

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

VX11-787-101

Identifier Type: -

Identifier Source: org_study_id