A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection with Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP)
- Conditions
- 10047438Respiratory Syncytial VirusRSV
- Registration Number
- NL-OMON49803
- Lead Sponsor
- Enanta Pharmaceuticals, Inc.
- Brief Summary
Trial never started
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 8
1. A full ICF signed and dated by the subject. (Note: Prior to signing the full
ICF, subjects will sign a Rapid Viral Screen ICF as described in inclusion
criterion #4.)
2. Male or female individuals aged 18 to 75 years, inclusive.
3. Up to 48 hours of URTI symptoms with at least one of the following symptoms:
Nasal discharge, nasal congestion, malaise/tiredness, headache, sinus
congestion, sneezing, sore throat, hoarseness, cough, shortness of breath,
respiratory wheeze, earache, and/or symptoms of fever.
Note: The duration of symptoms (not more than 48 hours) is to be measured from
the estimated time of onset of the first symptom.
4. After signing the Rapid Viral Screen ICF, positive for RSV infection and
negative for influenza virus based on rapid diagnostic screen of nasal (or
nasopharyngeal) swab samples.
5. Medically stable based on assessment of physical examination, medical
history, vital sign measurements, pulse oximetry (only for subjects with asthma
or COPD), and 12-lead ECG performed at Screening.
6. A body mass index >=18 kg/m2 and <=40 kg/m2.
7. Negative urine pregnancy test for women of childbearing potential as defined
in inclusion criterion #8.
8. A woman of childbearing potential who is sexually active with a male must
agree to use two effective methods of contraception from the date of Screening
until 30 days after her last dose of study drug. Effective methods of
contraception are defined as:
A condom for the male partner and at least one of the following for the female
subject:
a. Intrauterine device
b. Occlusive cap (diaphragm or cervical/vault caps)
c. Oral, injectable, implantable, transdermal, or intravaginal hormonal
contraceptive
Note: The above does not apply to a female subject who has a vasectomized male
as the sole partner or who is of nonchildbearing potential (ie, physiologically
incapable of becoming pregnant) as defined below:
a. Has had a complete hysterectomy >=3 months prior to dosing or
b. Has had a bilateral oophorectomy (ovariectomy) or
c. Has had a bilateral tubal ligation or fallopian tube inserts or
d. Is postmenopausal (a total cessation of menses for at least 2 years; Note:
Subjects with a cessation of menses between 1 to 2 years and a
follicle-stimulating hormone [FSH] level of >35 mIU/mL will also be
considered to be postmenopausal).
9. A male subject who has not had a vasectomy and is sexually active with a
woman of childbearing potential must agree to use effective contraception from
the date of Screening to 90 days after his last dose of study drug. Effective
contraception is defined as a condom and at least one of the following for a
female partner:
a. Intrauterine device
b. Occlusive cap (diaphragm or cervical/vault caps)
c. Oral, injectable, implantable, transdermal, or intravaginal contraceptive
Note: For a male subject who has had a vasectomy, use of a condom will still be
required.
10. Male subjects must agree to refrain from sperm donation from the date of
Screening until 90 days after his last dose of study drug.
11. Must be willing and able to adhere to the study assessments, visit
schedules, prohibitions, and restrictions, as described in this protocol.
Additional Inclusion Criteria for Subjects With Asthma
12. Physician-diagnosed asthma and currently receiving Global Initiative for <b
1. Clinical evidence of a lower respiratory tract infection, as determined by
the Investigator.
2. Anticipated need for hospitalization or emergency room care within 24 hours
of Screening.
3. Receipt of systemic antiviral, antibacterial, antifungal, or
antimycobacterial therapy within 7 days of Screening and for the duration of
the study.
4. Awareness of concomitant respiratory infections that are viral (other than
RSV), bacterial, or fungal, including systemic bacterial or fungal infections,
within 7 days of Screening.
5. SARS-CoV-2 positive within 28 days of Screening or at Screening following
signature of full ICF.
6. Frailty scale score >=4 at Screening.
7. History of chronic liver disease (eg, hemochromatosis, Wilson*s disease,
alpha-1 antitrypsin deficiency, autoimmune hepatitis, nonalcoholic
steatohepatitis, and/or alcoholic liver disease); a history of biliary disease
(eg, primary sclerosing cholangitis, cholecystitis, choledocholithiasis); or a
history of portal hypertension. A diagnosis of hepatic steatosis (fatty liver)
is not exclusionary.
8. Heart disease: any congenital heart disease, acute or chronic heart failure,
ischemic heart disease, congenital long QT syndrome, or any clinical
manifestation resulting in QT interval prolongation. Note: Subjects with
controlled hypertension without cardiac compromise will be allowed to enroll.
See exclusion criterion #18 for prohibited medications.
9. Neurological and neurodevelopmental disorders (including disorders of the
brain, spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy
[seizure disorders], stroke, muscular dystrophy, or spinal cord injury). Note:
Minor neurological disorders (eg, past concussions, headaches, migraine) are
allowed.
10. Malignant tumor or history of malignancy that may interfere with the aims
of the study or a subject completing the study.
11. Prior receipt or the subject is waiting to receive a bone marrow, stem
cell, or solid organ transplantation.
12. Diagnosis of cystic fibrosis.
13. Known positive human immunodeficiency virus, active hepatitis A virus
infection, chronic hepatitis B virus infection, and/or current or treated
hepatitis C virus infection.
14. Prior or planned ileal resection or bariatric surgery. Note: Subjects who
have undergone gastric surgeries that do not affect drug absorption (eg,
gastric band or gastric sleeve procedures) will be allowed to participate if
they are stable for at least 1 year prior to
Screening. Gastrectomy will be allowed if stable for at least 3 years prior to
Screening.
15. Pregnant or nursing female subjects.
16. History of alcohol addiction or current heavy alcohol use defined as: >14
standard drinks per week and/or >=4 standard drinks per occasion for males and
>7 standard drinks per week and/or >=3 standard drinks per occasion for females.
A standard drink is 12 oz of beer (5% alcohol), 5 oz table wine (12% alcohol),
or 1.5 oz of spirits (40% alcohol).
17. Known or suspected, in the opinion of the Investigator, renal disease or
renal impairment.
18. Twelve-lead ECG demonstrating a QT interval corrected for heart rate
according to Fridericia (QTcF) that is >500 msec or other clinically relevant
abnormalities as judged by the Investigator at Screening.
19. Use of or intention to use excluded or c
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>• Effect of EDP-938 compared to placebo on RSV infection clinical symptoms<br /><br>measured as the total symptom score (TSS) area under the curve (AUC) from Day 1<br /><br>through Day 14</p><br>
- Secondary Outcome Measures
Name Time Method