A Study of S-033188 Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza



Status:Active, not recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - 64
Updated:4/1/2017
Start Date:November 2016
End Date:October 2017

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A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza

The primary objective of this study is to evaluate the efficacy of a single, oral dose of
S-033188 compared with placebo by measuring the time to alleviation of symptoms in patients
with uncomplicated influenza virus infection.


Inclusion Criteria:

1. Patients who are able to understand the study and comply with all study procedures,
and willing to provide written informed consent/assent prior to the predose
examinations appropriately. As for adolescent patients, informed consent/assent of
voluntary participation should be obtained in accordance with local requirements

2. Male or female patients aged ≥ 12 to ≤ 64 years at the time of signing the informed
consent/assent form.

3. Patients with a diagnosis of influenza virus infection confirmed by all of the
following:

1. Fever ≥ 38ºC (axillary) in the predose examinations or > 4 hours after dosing of
antipyretics if they were taken

2. At least one of the following general systemic symptoms associated with
influenza are present with a severity of moderate or greater

- Headache

- Feverishness or chills

- Muscle or joint pain

- Fatigue

3. At least one of the following respiratory symptoms associated with influenza are
present with a severity of moderate or greater

- Cough

- Sore throat

- Nasal congestion

4. The time interval between the onset of symptoms and the predose examinations is 48
hours or less. The onset of symptoms is defined as either:

1. Time of the first increase in body temperature (an increase of at least 1ºC from
normal body temperature)

2. Time when the patient experiences at least one general or respiratory symptom

5. Women of childbearing potential who agree to use a highly effective method of
contraception for 3 months after the first dose of study drug

Exclusion Criteria:

1. Patients with severe influenza virus infection requiring inpatient treatment.

2. Patients aged ≥ 20 years with known allergy to oseltamivir (Tamiflu®).

3. Patients with any of the following risk factors

1. Women who are pregnant or within 2 weeks post-partum

2. Residents of long-term care facilities (eg, welfare facilities for the elderly,
nursing homes)

3. Chronic respiratory diseases including bronchial asthma

4. Neurological and neurodevelopmental disorders including disorders of the brain,
spinal cord, peripheral nerve, and muscle (eg, cerebral palsy, epilepsy [seizure
disorders], stroke, intellectual disability, moderate to severe developmental
delay, muscular dystrophy, or spinal cord injury)

5. Heart disease (such as congenital heart disease, congestive heart failure, or
coronary artery disease), excluding hypertension without any other heart-related
symptoms)

6. American Indians and Alaskan natives

7. Blood disorders (such as sickle cell disease)

8. Endocrine disorders (including diabetes mellitus)

9. Kidney disorders

10. Liver disorders

11. Metabolic disorders

12. Compromised immune system (including patients receiving immunosuppressant
therapy, or those with cancer or human immunodeficiency virus [HIV] infection)

13. Morbid obesity (body mass index [BMI] ≥ 40)

4. Patients unable to swallow tablets or capsules.

5. Patients who have previously received S-033188.

6. Patients weighing < 40 kg

7. Patients who have been exposed to an investigational drug within 30 days prior to the
predose examinations.

8. Women who are breastfeeding or have a positive pregnancy test in the predose
examinations. The following female patients who have documentation of either a or b
below do not need to undergo a pregnancy test in the predose examinations:

1. Postmenopausal (defined as cessation of regular menstrual periods for 2 years or
more and confirmed by a follicle-stimulating hormone test) women

2. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or
tubal ligation

9. Patients with concurrent infections requiring systemic antimicrobial and/or antiviral
therapy at the predose examinations.

10. Patients who have received peramivir, laninamivir, oseltamivir, zanamivir,
rimantadine, umifenovir, or amantadine within 30 days prior to the predose
examinations.

11. Patients who have received an investigational monoclonal antibody for a viral disease
in the last year.

12. Patients with severe underlying diseases.

13. Patients with known creatinine clearance ≤ 60 mL/min.

14. Patients who, in the opinion of the investigator, would be unlikely to comply with
required study visits, self-assessments, and interventions
We found this trial at
117
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Gulf Shores, Alabama 36542
1785
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Gulf Shores, AL
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Addison, Texas 75001
1220
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Athens, Alabama 35611
1762
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Austin, Texas
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Avon, Indiana 46123
1780
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Baytown, Texas 77521
1380
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Bellevue, Nebraska
1300
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Berlin, New Jersey
2388
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Birmingham, Alabama
1785
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Boynton Beach, Florida
2307
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Bozeman, Montana
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Brampton, Ontario
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Brooklyn, New York 11201
2186
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Canoga Park, California 91303
34
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Canton, Ohio
2047
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Carrollton, Texas 75010
1217
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Centennial, Colorado 80249
818
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Centerville, Ohio 45459
2068
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Channelview, Texas
1372
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Charleston, South Carolina
2185
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Charlotte, North Carolina 28210
2101
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Cincinnati, Ohio
1879
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Clearwater, Florida
2116
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Columbus, Georgia
1902
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Corpus Christi, Texas 78413
1293
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Costa Mesa, California 92626
30
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Dallas, Texas
1224
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Dayton, Ohio
1897
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Decatur, Georgia
1924
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Denver, Colorado
817
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DeSoto, Texas 75115
1223
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Diamond Bar, California 91765
12
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Doral, Florida 33166
2311
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Draper, Utah 84020
559
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Ellensburg, Washington 98926
902
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Evansville, Indiana
1714
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Fayetteville, North Carolina 28314
2213
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Fort Lauderdale, Florida 33308
2315
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Fort Myers, Florida 33912
2205
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Franklin, Tennessee 37064
1759
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Gainesville, Florida 32607
2105
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Garden City, New York 11530
2452
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Gold River, California 95670
362
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Greenbrae, California 94904
367
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Harleysville, Pennsylvania 19438
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Hawaiian Gardens, California 90716
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Hialeah, Florida
2314
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Hickory, North Carolina 28601
2069
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Houston, Texas
1357
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Huntington Beach, California 92647
28
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Huntsville, Alabama 35801
1784
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Jackson, Tennessee 38305
1653
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1837
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Kissimmee, Florida 34741
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La Crosse, Wisconsin 54601
1578
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Lake Charles, Louisiana
1470
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Lake Worth, Florida 33461
2307
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Lauderdale Lakes, Florida 33319
2310
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Lexington, North Carolina 27292
2128
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Little Rock, Arkansas
1463
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Lomita, California 90171
25
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Long Beach, California
23
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Los Angeles, California
13
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McAllen, Texas 78503
1298
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Metairie, Louisiana 70006
1650
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Miami, Florida
2322
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Mishawaka, Indiana 46544
1803
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Mooresville, North Carolina
2099
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Morganton, North Carolina 28655
2049
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Nashville, Tennessee
1763
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New Orleans, Louisiana 70112
1655
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New Tazewell, Tennessee 37825
1938
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Norco, California 92860
28
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North Hollywood, California
22
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Northglenn, Colorado 80234
822
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Norwalk, California 90650
12
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Oklahoma City, Oklahoma
1165
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Omaha, Nebraska
1297
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Orlando, Florida
2184
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Oxnard, California 93030
67
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Oxon Hill, Maryland 20745
2284
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Palos Verdes, California 90274
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Paramount, California 90723
15
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Pembroke Pines, Florida 33026
2314
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Pharr, Texas 78577
1300
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Phoenix, Arizona
343
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Plano, Texas
1227
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Rapid City, South Dakota 57702
1049
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Rialto, California
36
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Salt Lake City, Utah
570
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San Angelo, Texas 76904
1035
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San Antonio, Texas
1188
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San Diego, California 92119
106
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San Marino, California 91108
6
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San Ramon, California 94582
338
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Sandy Springs, Georgia 30328
1917
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Scottdale, Pennsylvania 15683
2141
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Smithfield, Pennsylvania 15478
2130
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Smyrna, Tennessee 37167
1678
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