NCT01561807

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

September 2, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

March 19, 2012

Last Update Submit

August 31, 2016

Conditions

Influenza Virus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • 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

  • Composite symptom score AUC

    up to 8 days

  • +7 more secondary outcomes

Study Arms (4)

787 low dose

EXPERIMENTAL

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

Drug: VX-787

787 high dose

EXPERIMENTAL

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

Drug: VX-787

Placebo low dose

EXPERIMENTAL

Matching placebo low dose capsule, taken orally for 5 days

Drug: Placebo

Placebo high dose

EXPERIMENTAL

Matching placebo high dose capsule, taken orally for 5 days

Drug: Placebo

Interventions

VX-787DRUG
787 high dose787 low dose
PlaceboDRUG
Placebo high dosePlacebo low dose

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Interventions

pimodivir

Study Officials

  • Jose Trevejo, MD, PhD

    Vertex Pharmaceuticals Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 23, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2012

Last Updated

September 2, 2016

Record last verified: 2016-08

Locations

GB(1)