Study of Acute Uncomplicated Seasonal Influenza A in Adul... | NCT02342249

ID	Type	Description
VX-787FLZ2001	Other Identifier	Janssen Research & Development, LLC
VX14-787-103	Other Identifier	Janssen Research & Development, LLC
2014-004068-39	EudraCT Number

Status Module

Name	Class
Janssen Pharmaceuticals	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VX-787 Placebo BID + Oseltamivir Placebo BID	Placebo Comparator	Subjects will receive 10 doses of matching placebo of VX-787 and Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.	Drug: Placebo
VX-787 300 mg BID + Oseltamivir Placebo BID	Active Comparator	Subjects will receive 10 doses of VX-787 300 milligram (mg) tablet along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.	Drug: VX-787 300 mg Drug: Placebo
VX-787 600 mg BID + Oseltamivir Placebo BID	Active Comparator	Subjects will receive 10 doses of VX-787 600 mg (2*300 mg tablets) along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.	Drug: VX-787 600 mg Drug: Placebo
VX-787 600 mg BID + Oseltamivir 75 mg BID	Active Comparator	Subjects will receive 10 doses of VX-787 600 mg tablets (2*300 mg tablets) along with 75 mg Oseltamivir capsule twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.	Drug: VX-787 600 mg Drug: Oseltamivir 75 mg

Name	Type	Description	Arm Group Labels	Other Names
VX-787 300 mg	Drug	A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.	VX-787 300 mg BID + Oseltamivir Placebo BID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the curve (AUC) of the log10 Nasal Viral Load on Day 8	Area under the curve (AUC) of the log10 nasal viral load is measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).	Day 8

Secondary Outcomes

Measure	Description	Time Frame
Time to Resolution of Influenza Symptoms After Initiation of Study Drug	Estimated acceleration factors expressed as the ratio of the time to resolution of influenza symptoms as compared to placebo time to negativity. Resolution of influenza symptoms was the time of the first of 3 evaluations (over 24 hours) in which all symptom scores for each of the 3 assessments are 0 or 1 for all 7 primary influenza symptoms (cough, sore throat, headache, nasal stuffiness, feverishness or chills, muscle or joint pain, and fatigue) of the Flu-iiQ^TM. The Flu-iiQ^TM questionnaire consists of 4 modules, including 1 module assessing influenza symptoms, 1 module assessing the impact of influenza on normal functioning, and 2 modules assessing the impact of influenza on the subject's emotional state. The Influenza Symptom assessment (Module 1) is scored on a 4 point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) for each of 10 influenza symptoms.

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Part A

Willing and able to comply with the NP swab procedure
Subject will sign and date an informed consent form (ICF)
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.
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

Willing and able to comply with study requirements including treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures
Subject will sign and date an ICF
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".
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)
Positive Rapid Influenza Diagnostic Test for influenza type A
Body mass index (BMI) of 18.0 to 33.0 kg/m2, inclusive, and a total body weight >50 kg

Exclusion Criteria: Part B

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.
Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal tract surgery, except appendectomy).
Immunized (intranasal or injected vaccine) against influenza in the 6 months before study entry.
At Screening, an ECG that is abnormal and deemed by the investigator(s) to be clinically significant.
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.
For male subjects, unwilling to comply with contraception requirements as outlined in the study protocol.
Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the first study drug dose.
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.
History of excessive alcohol consumption.
History of known or current usage of drugs of abuse.
Hospitalized subjects and subjects with bacterial infections requiring systemic antibacterial agents at the time of screening.

Facility	Status	City	State	ZIP	Country	Contacts
		Athens	Alabama		United States

ID	Term
C000605010	pimodivir
D053139	Oseltamivir

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D053138	Cyclohexenes
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons