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
sites
Draper, Utah 84020
775
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Draper, UT
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Addison, Texas 75001
335
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Addison, TX
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Athens, Alabama 35611
637
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Athens, AL
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Austin, Texas
517
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Avon, Indiana 46123
630
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Avon, IN
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Baytown, Texas 77521
577
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Bellevue, Nebraska
255
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Berlin, New Jersey
1237
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Birmingham, Alabama
683
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Boynton Beach, Florida
1291
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Bozeman, Montana
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Brooklyn, New York 11201
1056
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Canoga Park, California 91303
1184
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Canton, Ohio
902
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Carrollton, Texas 75010
335
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Centennial, Colorado 80249
400
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Centerville, Ohio 45459
918
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Channelview, Texas
572
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Charleston, South Carolina
1064
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Charlotte, North Carolina 28210
957
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Cincinnati, Ohio
725
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Clearwater, Florida
1100
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Columbus, Georgia
811
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Corpus Christi, Texas 78413
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Costa Mesa, California 92626
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Dallas, Texas
348
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Dayton, Ohio
746
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Decatur, Georgia
805
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Denver, Colorado
409
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DeSoto, Texas 75115
360
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Diamond Bar, California 91765
1145
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Doral, Florida 33166
1311
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Ellensburg, Washington 98926
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Evansville, Indiana
559
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Fayetteville, North Carolina 28314
1067
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Fort Lauderdale, Florida 33308
1307
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Fort Myers, Florida 33912
1206
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Franklin, Tennessee 37064
618
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Gainesville, Florida 32607
1049
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Garden City, New York 11530
1306
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Gold River, California 95670
1270
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Greenbrae, California 94904
1343
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Gulf Shores, Alabama 36542
776
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Harleysville, Pennsylvania 19438
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Hawaiian Gardens, California 90716
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Hickory, North Carolina 28601
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Houston, Texas
569
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Huntington Beach, California 92647
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Huntsville, Alabama 35801
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Jackson, Tennessee 38305
520
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1055
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Kalamazoo, Michigan
718
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Kissimmee, Florida 34741
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La Crosse, Wisconsin 54601
541
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582
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Lake Worth, Florida 33461
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Lauderdale Lakes, Florida 33319
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Lexington, North Carolina 27292
979
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371
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1178
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798
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Metairie, Louisiana 70006
693
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1322
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Mishawaka, Indiana 46544
675
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Mooresville, North Carolina
953
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Morganton, North Carolina 28655
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New Orleans, Louisiana 70112
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New Tazewell, Tennessee 37825
788
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Norco, California 92860
1133
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North Hollywood, California
1173
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Northglenn, Colorado 80234
412
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Norwalk, California 90650
1163
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Oklahoma City, Oklahoma
158
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Omaha, Nebraska
260
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Orlando, Florida
1141
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Oxnard, California 93030
1216
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Oxon Hill, Maryland 20745
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Palos Verdes, California 90274
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Paramount, California 90723
1167
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Pembroke Pines, Florida 33026
1309
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Pharr, Texas 78577
798
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852
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332
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Rapid City, South Dakota 57702
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1119
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779
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459
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576
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Sandy Springs, Georgia 30328
796
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Scottdale, Pennsylvania 15683
991
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Smithfield, Pennsylvania 15478
978
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Smyrna, Tennessee 37167
538
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