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

Purpose

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.

Condition	Intervention	Phase
Influenza Virus	Drug: VX-787	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

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 [ Time Frame: up to 11 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Total tissue count and total mucus weight after viral inoculation [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
Sequence analysis of the relevant target region of influenza [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
Pharmacokinetic (PK) parameters of VX-787 [ Time Frame: 8 days ] [ Designated as safety issue: No ]
As measured by AUC, Cmax, tmax
Composite symptom score AUC [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
Duration of viral shedding by cell culture and/or RT-PCR [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
Peak viral shedding titer by cell culture and/or RT-PCR [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
Time to resolution from peak viral shedding by cell culture and/or RT-PCR [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
Time to peak of composite sympton score, duration, and time to resolution of composite score from peak [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
Peak severity of symptoms after viral inoculation [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
Duration of influenza-like illness after viral inoculation [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]

Enrollment:	140
Study Start Date:	March 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 787 low dose	Drug: VX-787 low dose capsule, taken orally for 5 days
Experimental: 787 high dose	Drug: VX-787 high dose capsule, taken orally for 5 days
Experimental: Placebo low dose Capsule matching the low dose	Drug: VX-787 low dose capsule, taken orally for 5 days
Experimental: Placebo high dose Capsule matching the high dose	Drug: VX-787 high dose capsule, taken orally for 5 days

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561807

Locations

United Kingdom

London, United Kingdom

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Investigators

Study Director:

Jose Trevejo, MD, PhD

Vertex Pharmaceuticals Incorporated

More Information

No publications provided

Responsible Party:	Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT01561807 History of Changes
Other Study ID Numbers:	VX11-787-101
Study First Received:	March 19, 2012
Last Updated:	December 18, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Additional relevant MeSH terms:

Influenza, Human
Virus Diseases
Orthomyxoviridae Infections

RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013