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

Primary Purpose

Influenza Virus

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
VX-787
Placebo
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza Virus

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

787 low dose

787 high dose

Placebo low dose

Placebo high dose

Arm Description

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

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

Matching placebo low dose capsule, taken orally for 5 days

Matching placebo high dose capsule, taken orally for 5 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs.
Total tissue count and total mucus weight after viral inoculation
Sequence analysis of the relevant target region of influenza
Pharmacokinetic (PK) parameters of VX-787
As measured by AUC, Cmax, tmax
Composite symptom score AUC
Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment
Duration of viral shedding by cell culture and/or RT-PCR
Peak viral shedding titer by cell culture and/or RT-PCR
Time to resolution from peak viral shedding by cell culture and/or RT-PCR
Time to peak of composite sympton score, duration, and time to resolution of composite score from peak
Peak severity of symptoms after viral inoculation
Duration of influenza-like illness after viral inoculation

Full Information

First Posted
March 19, 2012
Last Updated
August 31, 2016
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01561807
Brief Title
A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza Virus
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
787 low dose
Arm Type
Experimental
Arm Description
VX-787 low dose capsule, taken orally for 5 days
Arm Title
787 high dose
Arm Type
Experimental
Arm Description
VX-787 high dose capsule, taken orally for 5 days
Arm Title
Placebo low dose
Arm Type
Experimental
Arm Description
Matching placebo low dose capsule, taken orally for 5 days
Arm Title
Placebo high dose
Arm Type
Experimental
Arm Description
Matching placebo high dose capsule, taken orally for 5 days
Intervention Type
Drug
Intervention Name(s)
VX-787
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Time Frame
up to 11 days
Secondary Outcome Measure Information:
Title
Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs.
Time Frame
up to 33 days
Title
Total tissue count and total mucus weight after viral inoculation
Time Frame
up to 10 days
Title
Sequence analysis of the relevant target region of influenza
Time Frame
up to 8 days
Title
Pharmacokinetic (PK) parameters of VX-787
Description
As measured by AUC, Cmax, tmax
Time Frame
8 days
Title
Composite symptom score AUC
Time Frame
up to 8 days
Title
Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment
Time Frame
up to 8 days
Title
Duration of viral shedding by cell culture and/or RT-PCR
Time Frame
up to 8 days
Title
Peak viral shedding titer by cell culture and/or RT-PCR
Time Frame
up to 8 days
Title
Time to resolution from peak viral shedding by cell culture and/or RT-PCR
Time Frame
up to 8 days
Title
Time to peak of composite sympton score, duration, and time to resolution of composite score from peak
Time Frame
up to 8 days
Title
Peak severity of symptoms after viral inoculation
Time Frame
up to 8 days
Title
Duration of influenza-like illness after viral inoculation
Time Frame
up to 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Trevejo, MD, PhD
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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