Influenza VirusPhase 2NCT01561807
A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza Virus
A Phase 2 study testing VX-787 in people with Influenza Virus, run by Vertex Pharmaceuticals Incorporated at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Virus
- What is being tested?
- VX-787
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- VX-787, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-787Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 787 low dose | Experimental | VX-787 low dose capsule, taken orally for 5 days Receives: Drug: VX-787 |
| 787 high dose | Experimental | VX-787 high dose capsule, taken orally for 5 days Receives: Drug: VX-787 |
| Placebo low dose | Experimental | Matching placebo low dose capsule, taken orally for 5 days Receives: Drug: Placebo |
| Placebo high dose | Experimental | Matching placebo high dose capsule, taken orally for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: up to 33 days
Total tissue count and total mucus weight after viral inoculation
Measured: up to 10 days
Sequence analysis of the relevant target region of influenza
Measured: up to 8 days
Pharmacokinetic (PK) parameters of VX-787
As measured by AUC, Cmax, tmax
Measured: 8 days
Composite symptom score AUC
Measured: up to 8 days
Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment
Measured: up to 8 days
Duration of viral shedding by cell culture and/or RT-PCR
Measured: up to 8 days
Peak viral shedding titer by cell culture and/or RT-PCR
Measured: up to 8 days
Time to resolution from peak viral shedding by cell culture and/or RT-PCR
Measured: up to 8 days
Time to peak of composite sympton score, duration, and time to resolution of composite score from peak
Measured: up to 8 days
Peak severity of symptoms after viral inoculation
Measured: up to 8 days
Duration of influenza-like illness after viral inoculation
Measured: up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VirusStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Trevejo, MD, PhD, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561807
- Sponsor's protocol ID
- VX11-787-101
- Status last verified
- Aug 2016
- First submitted
- 19 Mar 2012
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01561807
- Acronym / sponsor ID
- VX11-787-101
- Conditions
- Influenza Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 787 low dose | Experimental | Drug: VX-787VX-787 low dose capsule, taken orally for 5 days |
| 787 high dose | Experimental | Drug: VX-787VX-787 high dose capsule, taken orally for 5 days |
| Placebo low dose | Experimental | Drug: PlaceboMatching placebo low dose capsule, taken orally for 5 days |
| Placebo high dose | Experimental | Drug: PlaceboMatching placebo high dose capsule, taken orally for 5 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VX-787 | Drug | 787 high dose, 787 low dose |
| Placebo | Drug | Placebo high dose, Placebo low dose |
Primary outcome
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
12 secondary outcomes
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
Total tissue count and total mucus weight after viral inoculation
Time frame: up to 10 days
Sequence analysis of the relevant target region of influenza
Time frame: up to 8 days
Pharmacokinetic (PK) parameters of VX-787
Time frame: 8 days
Composite symptom score AUC
Time frame: up to 8 days
Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment
Time frame: up to 8 days
Duration of viral shedding by cell culture and/or RT-PCR
Time frame: up to 8 days
Peak viral shedding titer by cell culture and/or RT-PCR
Time frame: up to 8 days
Time to resolution from peak viral shedding by cell culture and/or RT-PCR
Time frame: up to 8 days
Time to peak of composite sympton score, duration, and time to resolution of composite score from peak
Time frame: up to 8 days
Peak severity of symptoms after viral inoculation
Time frame: up to 8 days
Duration of influenza-like illness after viral inoculation
Time frame: up to 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Trevejo, MD, PhD study director
Vertex Pharmaceuticals Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-787 in people with Influenza Virus, run by Vertex Pharmaceuticals Incorporated at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.