Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects



Status:Recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 64
Updated:4/21/2016
Start Date:December 2014
End Date:May 2016
Contact:Medical Information
Email:medicalinfo@vrtx.com
Phone:617.341.6777

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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

The primary objective of the study is to evaluate the time to resolution of influenza
symptoms in adults with acute uncomplicated seasonal influenza A following administration of
VX-787, with and without concomitant oseltamivir.


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.
We found this trial at
133
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Garden Grove, California 92844
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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900 East 30th Street
Austin, Texas 78705
512-480-9660
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175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
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304 Northeast 1st Street
Chiefland, Florida 32626
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4110 Center Point Dr.
Fort Myers, Florida 33916
239-936-4421
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Kissimmee, Florida 34741
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Ste 205, 10796 Pines Boulevard
Pembroke Pines, Florida 33026
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
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Alexandria, Virginia 22304
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Amarillo, Texas 79106
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760 North Euclid Street
Anaheim, California 92801
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Anaheim, California 92805
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Arlington, Texas 76012
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Austin, Texas 78735
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Bardstown, Kentucky 40004
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Belton, Missouri 64012
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Birmingham, Alabama 35242
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Borgerhout, 2140
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Boynton Beach, Florida 33437
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Bristol, Tennessee 37620
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Brooklyn, New York 11207
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Chula Vista, California 91910
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Chula Vista, California 91911
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Clinton, Utah 84015
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Colorado Springs, Colorado 80918
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Columbus, Georgia 31904
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Council Bluffs, Iowa 51501
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Dallas, Texas 75234
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El Cajon, California 92020
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Encino, California 91436
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Fremont, Nebraska 68025
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Gulf Shores, Alabama 36542
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Harleysville, Pennsylvania 19438
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Hickory, North Carolina 28601
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Huber Heights, Ohio 45424
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Jenkintown, Pennsylvania 19046
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Johnston, Rhode Island 02919
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La Mesa, California 91942
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Miami, Florida 33125
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286 Westward Drive
Miami, Florida 33135
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Miami, Florida 33175
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286 Westward Drive
Miami, Florida 33142
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Miami, Florida 33144
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Morehead City, North Carolina 28557
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Morganton, North Carolina 28655
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