Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02342249
• Date of registration: 07/01/2015
• Prospective Registration: No
• Primary sponsor: Janssen Research & Development, LLC
• Public title: Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
• Scientific title: A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study of 2 Dose Levels of VX 787 Administered as Monotherapy and One Dose Level of VX-787 Administered in Combination With Oseltamivir for the Treatment of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
• Date of first enrolment: December 11, 2014
• Target sample size: 292
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02342249
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Bulgaria, Canada, Estonia, Germany, Latvia, Puerto Rico, South Africa, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria: Part A

1. Willing and able to comply with the NP swab procedure

2. Subject will sign and date an informed consent form (ICF)

3. Presenting to the clinic with symptoms suggestive of a diagnosis of acute influenza.
Symptoms include oral temperature =38°C (100.4°F) within the prior 24 hours, at least
1 respiratory symptom AND at least 1 systemic symptom.

4. Understand that no study treatment will be provided to subjects in Part A but that
they are free to receive any treatment considered appropriate by their physician

Part B

1. Willing and able to comply with study requirements including treatment plan, study
restrictions, laboratory tests, contraceptive guidelines, and other study procedures

2. Subject will sign and date an ICF

3. Present to the clinic with symptoms suggestive of a diagnosis of acute influenza.
Symptoms include documented oral temperature =38°C (100.4°F) any time during the
screening process, at least 1 respiratory symptom AND at least 1 systemic symptom,
both scored as at least "moderate".

4. The time of onset of flu-like symptoms to the time anticipated for the start of
treatment must be =48 hours. Onset of symptoms is defined as the first time (within 1
hour) the subject becomes aware of respiratory or systemic symptoms compatible with
the flu or experiences an oral temperature =38°C (100.4°F)

5. Positive Rapid Influenza Diagnostic Test for influenza type A

6. Body mass index (BMI) of 18.0 to 33.0 kg/m2, inclusive, and a total body weight >50 kg

Exclusion Criteria: Part B

1. History of any illness or any clinical condition that, in the opinion of the
investigator or the subject's general practitioner, might confound the results of the
study or pose an additional risk in administering study drug(s) to the subject.

2. Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy,
or other gastrointestinal tract surgery, except appendectomy).

3. Immunized (intranasal or injected vaccine) against influenza in the 6 months before
study entry.

4. At Screening, an ECG that is abnormal and deemed by the investigator(s) to be
clinically significant.

5. For female subjects: Pregnant or nursing subjects and female subjects of childbearing
potential who are unwilling or unable to use an acceptable method of contraception as
outlined in this protocol.

6. For male subjects, unwilling to comply with contraception requirements as outlined in
the study protocol.

7. Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the
first study drug dose.

8. Use of the following medications:

- Influenza antiviral medication (oseltamivir, zanamivir, rimantidine, or
amantadine) within 14 days or ribavirin within 6 months of screening.

- Substrates of OATP1B1 and/or OATP1B3, including atrasentan, bosentan, ezetimibe,
glyburide, irinotecan, repaglinide, rifampin, telmisartan, valsartan, and
olmesartan, from Day 1 through the last dose of study drug. "Statins" (i.e., HMG
CoA reductase inhibitors) may be continued, but subjects should be cautioned and
observed for potential "statin"-related toxicity. Alternatively, subjects can
abstain from statins for the duration of study drug dosing.

- Strong inhibitors or inducers of CYP3A metabolism, including carbamazepine,
clarithromycin, HIV and HCV protease inhibitors, itraconazole, ketoconazole,
nefazodone, phenytoin, posaconazole, rifampin, St. John's wort, telithromycin,
and voriconazole from 2 weeks prior to the first dose of study drug until the
last PK sample is collected on Day 8.

- An investigational drug or device 30 days before the first dose of study drug, 5
half lives before the first dose of study drug, or time determined by local
requirements, whichever is longest.

9. History of excessive alcohol consumption.

10. History of known or current usage of drugs of abuse.

11. Hospitalized subjects and subjects with bacterial infections requiring systemic
antibacterial agents at the time of screening.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Influenza A

Intervention(s)

Drug: Oseltamivir 75 mg

Drug: VX-787 300 mg

Drug: VX-787 600 mg

Drug: Placebo

Primary Outcome(s)

Area under the curve (AUC) of the log10 Nasal Viral Load on Day 8 [Time Frame: Day 8]

Secondary Outcome(s)

Viral sequence analysis to monitor for emergence of viral variants resistant to VX 787 and to oseltamivir [Time Frame: Day 14]

Pharmacokinetic parameters of VX787, as determined by population analysis [Time Frame: Day 14]

Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs [Time Frame: Day 14]

Clinical composite symptom scores [Time Frame: Day 14]

Antiviral effect and viral kinetics composite [Time Frame: Days 1 - 8]

Time to Resolution of Influenza Symptoms After Initiation of Study Drug [Time Frame: Baseline up to Day 14]

Secondary ID(s)

2014-004068-39

CR107745

VX-787FLZ2001

VX14-787-103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen Pharmaceuticals